Health Care Guideline

Diagnosis and Initial Treatment of Ischemic Stroke
ICSI has endorsed with qualifications the following American Heart Association (AHA)/American Stroke
Association (ASA) documents:•

2013 AHA/ASA Guidelines for the Early Management of Patients with Acute Ischemic Stroke•2015 AHA/ASA Focused Update of the 2013 Guidelines for the Early Management of Patients With
Acute Ischemic Stroke Regarding Endovascular Treatment•

2016 Scientific Rationale for the Inclusion and Exclusion Criteria for Intravenous Alteplase in Acute
Ischemic Stroke

The AHA/ASA’s original documents can be accessed at http://www.strokeassociation.org/STROKEORG/.

Using the ICSI endorsement process, this document has been reviewed by the ICSI Diagnosis and Initial
Treatment of Ischemic Stroke work group: Anderson D, Larson D, Ferguson A, Klaas J, Kushner F, Peterson
B, Sierzant T, Streib C, Thomson R.
The American Heart Association (AHA)/American Stroke Association (ASA) are not sponsors of, affiliatedwith or endorsers of ICSI or the ICSI Diagnosis and Initial Treatment of Ischemic Stroke work group. The
AHA/ASA has not reviewed ICSI’s processes for endorsement of guidelines. The following ICSI endorsement and conclusions are solely the consensus of the ICSI Diagnosis and Initial Treatment of Ischemic
Stroke work group using the ICSI Endorsement Process.
Please note, the previous ICSI Diagnosis and Initial Treatment of Ischemic Stroke guideline from July2012 is being retired.

www.icsi.org
Copyright © 2016 by Institute for Clinical Systems Improvement

Health Care Guideline:

Diagnosis and Initial Treatment of Ischemic Stroke
Acute Ischemic Stroke Algorithm
Eleventh Edition
December 2016

Patient presents withsigns and symptoms ofan acute stroke

Initial assessment
Exam: vitals, O2 (oxygen), monitor, record weight, NIHSSLabs:1) Glucose
2) INR/Cr/CBC (including platelets) – if there is no
suspicion that these are abnormal, do not delay head
CT or tPA
Unless emergently indicated do not delay imaging/IV tPA to
obtain EKG, CXR or place foley

Text in blue in this document
indicates a link.

Managehemorrhagic stroke

Negative for hemorrhage
Non-contrast head CT and
Positive for(resolved neurologicalhemorrhage consider CTA head and neck if deﬁcits)
Evaluate forit will not delay IV tPA (orMRI/MRA if readily available)

TIA

Negative for hemorrhage(continuing neurological deﬁcits)
Within 4.5 hours

Neurology consultation(if available and timely)

Admit to appropriate
level of carenoSymptom
onset?

> 4.5 hours or time of onset is unknown

Neurology consultation

Is tPA indicated based on
symptoms (causing measurable
neurological deﬁcits) and can begiven within a 4.5 hour
time frame?
yes

IV tPA
contraindicated?

yes

Is patient a candidate for
intra-arterial treatment?

noAdmit to appropriate
level of carenoAdmit to appropriate
level of carenoyes

• Place 2 IVs of adequate size forcontrast administration• Treat SBP if > 185, DBP if > 110• Administer IV tPA (avoid signiﬁcantdelays seeking consult, IV tPA is
standard of care)• Post IV tPA monitoring

Perform CTA head andneck if not alreadyobtained on initial
imaging

Is proximal large vessel
occlusion with small
ischemic burdenpresent?
yes

Is intra-arterial
treatment
available?

noConsider transfer tofacility with intra-arterial
treatment capabilities

yes

Treat

Return to Table of Contents

www.icsi.org
Copyright © 2016 by Institute for Clinical Systems Improvement

1Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Table of Contents
Work Group
Co-LeadersDavid Anderson, MD
Neurology, University of
Minnesota Physicians andHennepin County Medical
CenterDavid Larson, MD
Emergency Medicine,
Ridgeview Medical CenterWork Group Members
Fairview Health Services
Ann Ferguson, MD
Internal Medicine
HealthEast Care System
Tess Sierzant, MS, RN
Neurology Nursing
Lakeview Hospital
Bjorn Peterson, MD
Emergency Medicine
Mayo Clinic
James Klaas, MD
Neurology

Minneapolis Clinic of
Neurology
Ruth Marie Thomson, DO
Vascular Neurology
Park Nicollet HealthServices
Fadoua Kushner, PharmD
Pharmacy
University of Minnesota
Physicians
Christopher Streib, MD
Vascular Neurology

ICSI Staff
Jodie Dvorkin, MD, MPH
Project Manager/HealthCare Consultant
Senka Hadzic, MPH
Clinical Systems
Improvement Facilitator

Algorithm (Acute Ischemic Stroke)......................................................................................1
Evidence Grading..................................................................................................................3

Foreword............................................................................................................................... 4-6

Introduction...........................................................................................................................4
Endorsement of American Heart Association (AHA)/American Stroke Association (ASA)
Stroke Documents........................................................................................................ 4-6

Recommendations............................................................................................................ 7-47

Prehospital..................................................................................................................... 7-10
Public Stroke Education and Prehospital Stroke Management................................... 7-8
Designation of Stroke Centers and Stroke Care Quality Improvement
Process................................................................................................................... 8-10
Evaluation/Diagnosis................................................................................................... 10-13
Emergency Evaluation and Diagnosis of Acute Ischemic Stroke............................ 10-11
Early Diagnosis: Brain and Vascular Imaging: Recommendations for Patients With
Acute Cerebral Ischemic Symptoms That Have Not Yet Resolved..................... 12-13
Acute Management...................................................................................................... 14-47
General Supportive Care and Treatment of Acute Complications........................... 14-17
Intravenous Fibrinolysis (Endorsed Recommendations from the 2016 Scientific
Rationale for the Inclusion and Exclusion Criteria for Intravenous Alteplase in Acute
Ischemic Stroke)...................................................................................................... 18-33
Endovascular Interventions (Recommendations from the 2015 American Heart
Association/American Stroke Association Focused Update of the 2013 Guidelines
for the Early Management of Patients With Acute Ischemic Stroke Regarding
Endovascular Treatment).................................................................................... 34-40
Anticoagulants...............................................................................................................41
Antiplatelet Agents.................................................................................................. 41-42
Admission to the Hospital and General Acute Treatment(After Hospitalization)........................................................................................ 42-45
Treatment of Acute Neurological Complications.................................................... 45-47
Quality Improvement Support................................................................................... 48-52
Aims and Measures.............................................................................................................49
Measurement Specifications.................................................................................... 50-52

Supporting Evidence..................................................................................................... 53-64

References..................................................................................................................... 54-56
Appendix A – Literature Search Terms by Topic...........................................................57-58
Appendix B – ICSI Shared Decision-Making Model....................................................59-64

Disclosure of Potential Conflicts of Interest........................................................... 65-67
External Review and Acknowledgements.....................................................................68
Document History and Development....................................................................... 69-70

Document History...............................................................................................................69
ICSI Document Development and Revision Process..........................................................70

www.icsi.org
Institute for Clinical Systems Improvement

2Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Evidence Grading

The American Heart Association (AHA)/American Stroke Association (ASA) uses its own system for classifying recommendations and evaluating the levels of evidence. This system is explained in the AHA/ASA
stroke documents. Since this is an endorsement document, ICSI did not use its own system to evaluate thelevels of evidence or classify recommendations. In one instance where the level of evidence for a recommendation was upgraded, the work group used AHA/ASA's system. In all other instances, where newliterature was available to support the existing recommendations or qualification statement for an existing
recommendation, the new literature was cited. If there was no new literature on the topic, and the recommendation was still valid based on the existing practice and previous literature, no literature was cited.
Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

3Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Foreword
The American Heart Association/American Stroke Association (AHA/ASA) is not a sponsor of or affiliatedwith, nor does it endorse ICSI or the ICSI Diagnosis and Initial Treatment of Ischemic Stroke work group.
AHA/ASA has not reviewed ICSI's process for endorsement of guidelines. The following ICSI endorsement
and conclusions are solely the consensus of the ICSI Diagnosis and Initial Treatment of Ischemic Stroke
work group using the ICSI Endorsement Process.
Return to Table of Contents

Introduction

Stroke is the fifth leading cause of death in the United States and a leading cause of serious long-term
disability (Mozzafarian, 2015; Kochanek, 2014). Annually, approximately 800,000 people in the UnitedStates have a stroke, and 130,000 die (Centers for Disease Control and Prevention, 2016). Of all strokes,
87% are ischemic strokes (Mozaffarian, 2015). In Minnesota, ischemic stroke death rate – regardless ofgender and age group – is at 19 per 100,000, compared to the national rate of 20 per 100,000, for years 20112013 per the Centers for Disease Control and Prevention's Interactive Atlas of Heart Disease and Stroke.
In the United States, one person dies from stroke every four minutes, on average (Mozaffarian, 2015).
Therefore, time is of the essence in getting appropriate early care for persons with an onset of stroke symptoms. The recommendations in this guideline are for early management of stroke due to ischemic brainischemia/infarction. This guideline does not address stroke prevention, transient ischemic stroke (TIA) or
management of hemorrhagic stroke.

To increase access to appropriate early care for stroke, Minnesota passed legislation to authorize theMinnesota Department of Health (MDH) to designate hospitals as Acute Stroke-Ready Hospitals, Primary
Stroke Centers and Comprehensive Stroke Centers. In addition to hospital designation, the legislation
also included data collection and reporting, and standardization of EMS protocols. These changes have
led to 91 hospitals in Minnesota getting designated as stroke hospitals as of January 1, 2016, and 87% ofresidents living within 30 minutes of a designated stroke center, per MDH data. MDH provides training,education and other resources to the hospitals that want to become designated as stroke centers. The ICSIDiagnosis and Initial Treatment of Ischemic Stroke guideline work group strongly encourages the hospitals
to participate in this process.
Return to Table of Contents

Endorsement of American Heart Association (AHA)/American Stroke
Association (ASA) Stroke Documents
The ICSI Diagnosis and Initial Treatment of Ischemic Stroke guideline work group endorsed the content
and recommendations from three AHA/ASA documents (see below). For detailed explanation and evidence
supporting the recommendations, see the original documents. AHA/ASA provided writing group andreviewer group conflict of interest disclosures. These were reviewed and taken into consideration by the
ICSI Diagnosis and Initial Treatment of Ischemic Stroke work group. The AHA/ASA's original documents
can be accessed at http://www.strokeassociation.org/STROKEORG/.
1. 2013 AHA/ASA Guidelines for the Early Management of Patients with Acute Ischemic Stroke.
Full citation: Jauch EC, Saver JL, Adams HP Jr, Bruno A, Connors JJ, Demaerschalk BM, Khatri P,
McMullan PW Jr, Qureshi AI, Rosenfeld K, Scott PA, Summers DR, Wang DZ, Wintermark M, Yonas
H; on behalf of the American Heart Association Stroke Council, Council on Cardiovascular Nursing,Council on Peripheral Vascular Disease, and Council on Clinical Cardiology. Guidelines for the early
management of patients with acute ischemic stroke: a guideline for healthcare professionals from theAmerican Heart Association/American Stroke Association. Stroke 2013;44:870-947.
Return to Table of Contents
Institute for Clinical Systems Improvement

www.icsi.org
4Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Foreword

The literature search was conducted for studies published between January 2012 and March 2016 for any
new studies to update the recommendations in this document. For information on the types of studies
searched and the literature search terms, please see Appendix A, "Literature Search Terms by Topic."
The following sections content and recommendations were reviewed and endorsed:•

Public Stroke Education and Prehospital Stroke Management•

Designation of Stroke Centers and Stroke Care Quality Improvement Process•

Emergency Evaluation and Diagnosis of Acute Ischemic Stroke•

Early Diagnosis: Brain and Vascular Imaging: Recommendations for Patients With Acute Cerebral
Ischemic Symptoms That Have Not Yet Resolved•

General Supportive Care and Treatment of Acute Complications•

Anticoagulants•

Antiplatelet Agents•

Admission to the Hospital and General Acute Treatment (After Hospitalization)•

Treatment of Acute Neurological Complications

The following sections content and recommendations were reviewed and endorsed:•

Early Diagnosis: Brain and Vascular Imaging: Recommendations for Patients With Cerebral
Ischemic Symptoms That Have Resolved•

Intravenous Fibrinolysis•

Endovascular Interventions•

Volume Expansion, Vasodilators, and Induced Hypertension•

Neuroprotective Agents•

Surgical Interventions

2. 2015 AHA/ASA Focused Update of the 2013 Guidelines for the Early Management of Patients
With Acute Ischemic Stroke Regarding Endovascular Treatment.
Full citation: Powers WJ, Derdeyn CP, Biller J, Coffey CS, Hoh BL, Jauch EC, Johnston KC, Johnston
SC, Khalessi AA, Kidwell CS, Meschia JF, Ovbiagele B, Yavagal DR; on behalf of the American Heart
Association Stroke Council. 2015 American Heart Association/American Stroke Association focused
update of the 2013 guidelines for the early management of patients with acute ischemic stroke regarding
endovascular treatment: a guideline for healthcare professionals from the American Heart Association/
American Stroke Association. Stroke 2015;46:3020-35.
ICSI did not conduct literature search on the recommendations in this guideline since AHA/ASA's update
was recent. However, it was brought to the attention by work group members to include in the review
two studies published in 2016 on this topic. Those studies are Goyal, 2016 and Schönenberger, 2016.
Refer to the reference section for full citations on these studies.
Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

5Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Foreword

3. 2016 Scientific Rationale for the Inclusion and Exclusion Criteria for Intravenous Alteplase in
Acute Ischemic Stroke. Full citation: Demaerschalk BM, Kleindorfer DO, Adeoye OM, Demchuk
AM, Fugate JE, Grotta JC, Khalessi AA, Levy EI, Palesch YY, Prabhakaran S, Saposnik G, Saver JL,
Smith EE; on behalf of the American Heart Association Stroke Council and Council on Epidemiology
and Prevention. Scientific rationale for the inclusion and exclusion criteria for intravenous alteplase inacute ischemic stroke: a statement for healthcare professionals from the American Heart Association/
American Stroke Association. Stroke 2016;47:581-641.
ICSI did not conduct literature search on the recommendations in this guideline, since AHA/ASA's
update was recent.
Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

6Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations

Note: In this document, qualification statement signifies substantial qualification/change to the original AHA/ASA
recommendation, and recommendations with qualifications statements are labeled as "agree with qualification." Statements thatare comments only do not significantly change the original recommendation, and those recommendations are labeled as "agree."Prehospital
AHA/ASA Recommendation

AHA/ASA Class

Public Stroke Education and Prehospital Stroke Management
1. To increase both the number ofpatients who are treated and thequality of care, educational stroke
programs for physicians, hospital
personnel, and EMS personnel arerecommended (Class I; Level of
Evidence B). (Unchanged from theprevious guideline)

2. Activation of the 911 system bypatients or other members of the
public is strongly recommended (ClassI; Level of Evidence B). 911
Dispatchers should make stroke apriority dispatch, and transport times
should be minimized. (Unchanged fromthe previous guideline)

Class I: Benefit>>>Risk

ICSI Work Group
Consensus

New Literature
Support

Qualification Statement/
Comment
Agree

Procedure/Treatment
SHOULD be
performed/administered.

Class I: Benefit>>>Risk

Agree

Procedure/Treatment
SHOULD be
performed/administered.

Stroke symptoms should
prompt dispatchers to
upgrade the response to apriority dispatch, despitewhat local dispatch protocols
might recommend.

3. Pre-hospital care providers should
use prehospital stroke assessment
tools, such as the Los Angeles
Prehospital Stroke Screen or
Cincinnati Prehospital Stroke Scale(Class I; Level of Evidence B).
(Unchanged from the previous guideline)

Class I: Benefit>>>Risk

Agree

Procedure/Treatment
SHOULD be
performed/administered.

4. EMS personnel should begin theinitial management of stroke in thefield, as outlined in Table 4 (Class I;
Level of Evidence B). Development of a
stroke protocol to be used by EMS
personnel is strongly encouraged.
(Unchanged from the previous guideline)

Class I: Benefit>>>Risk

Research is ongoing toestablish valid and reliable
pre-hospital tools to identify
patients with acute large
artery occlusive strokes, asubgroup that benefits fromneurointerventional careoffered in only some centers,
as well as specialized triage
paradigms that improveoutcomes for such patients.

Procedure/Treatment
SHOULD be
performed/administered.

Ekundayo, 2013

Malekzadeh, 2015;
Oostema, 2015;
Rudd, 2015;
Brandler, 2014;
Baldereschi, 2012

Agree

Table 4 is on page 875 of2013 AHA/ASA guidelines
for the Early Management ofPatients with Acute Ischemic
Stroke.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

7

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

5. Patients should be transported
rapidly to the closest available
certified PSC or CSC or, if no such
centers exist, the most appropriate
institution that provides emergency
stroke care as described in thestatement (Class I; Level of Evidence
A). In some instances, this may
involve air medical transport andhospital bypass. (Revised from theprevious guideline)

AHA/ASA ClassClass I:
Benefit>>>Risk
Procedure/Treatment
SHOULD be
performed/administered.

6. EMS personnel should provide
prehospital notification to thereceiving hospital that a potential
stroke patient is en route so that theappropriate hospital resources may
be mobilized before patient arrival(Class I; Level of Evidence B).
(Revised from the previous guideline)

Class I:
Benefit>>>Risk

1. The creation of PSCs is
recommended (Class I; Level of
Evidence B). The organization ofsuch resources will depend on local
resources. The stroke system designof regional ASRHs and PSCs thatprovide emergency care and that areclosely associated with a CSC, which
provides more extensive care, hasconsiderable appeal. (Unchanged
from the previous guideline)

Class I:
Benefit>>>Risk

ICSI Work Group
Consensus
Qualification Statement/
Comment

Agree

Specific to Minnesota,
Acute Stroke-Ready
Hospital (ASRH) is areasonable option to PSC or
CSC.

Agree

New Literature
Support

Oostema, 2014;
Baldereschi, 2012

Oostema, 2014;
Baldereschi, 2012

Procedure/Treatment
SHOULD be
performed/administered.

Designation of Stroke Centers and Stroke Care Quality Improvement Process

2. Certification of stroke centers byan independent external body, such
as TJC or state health department,is recommended (Class I; Level of
Evidence B). Additional medical
centers should seek suchcertification. (Revised from theprevious guideline)

Agree

Switzer, 2015

Procedure/Treatment
SHOULD be
performed/administered.

Class I:
Benefit>>>Risk

Agree

Procedure/Treatment
SHOULD be
performed/administered.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

8Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

3. Healthcare institutions shouldorganize a multidisciplinary quality
improvement committee to review
and monitor stroke care quality
benchmarks, indicators, evidencebased practices, and outcomes (ClassI; Level of Evidence B). The
formation of a clinical process
improvement team and theestablishment of a stroke care databank are helpful for such quality ofcare assurances. The data repository
can be used to identify the gaps or
disparities in quality stroke care.
Once the gaps have been identified,
specific interventions can beinitiated to address these gaps or
disparities. (New recommendation)
4. For patients with suspected stroke,
EMS should bypass hospitals that do
not have resources to treat stroke andgo to the closest facility most capableof treating acute stroke (Class I; Levelof Evidence B). (Unchanged from theprevious guideline)
5. For sites without in-house imaging
interpretation expertise, teleradiology
systems approved by the Food andDrug Administration (FDA) or
equivalent organization arerecommended for timely review ofbrain CT and MRI scans in patientswith suspected acute stroke (Class I;
Level of Evidence B). (Newrecommendation)
6. When implemented within atelestroke network, teleradiology
systems approved by the FDA (orequivalent organization) are useful insupporting rapid imaging
interpretation in time for fibrinolysis
decision-making (Class I; Level of
Evidence B). (New recommendation)
7. The development of CSCs is
recommended (Class I; Level of
Evidence C). (Unchanged from theprevious guideline)

AHA/ASA ClassClass I:
Benefit>>>Risk

ICSI Work Group
Consensus

New Literature
Support

Qualification Statement/
Comment

Agree

Power, 2014

Procedure/Treatment
SHOULD be
performed/administered.

Class I: Benefit>>>Risk

Agree

Procedure/Treatment
SHOULD be
performed/administered.

Class I: Benefit>>>Risk

Agree

Procedure/Treatment
SHOULD be
performed/administered.

Class I: Benefit>>>Risk

Agree

Procedure/Treatment
SHOULD be
performed/administered.

Class I: Benefit>>>Risk

Agree

Panezai, 2013

Procedure/Treatment
SHOULD be
performed/administered.

Return to Table of Contents
Institute for Clinical Systems Improvement

www.icsi.org
9Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

8. Implementation of telestroke
consultation in conjunction withstroke education and training for
healthcare providers can be useful inincreasing the use of intravenous rtPAat community hospitals without accessto adequate onsite stroke expertise(Class IIa; Level of Evidence B). (Newrecommendation)

9. The creation of ASRHs can be
useful (Class IIa; Level of Evidence C).
As with PSCs, the organization of such
resources will depend on local
resources. The stroke system design ofregional ASRHs and PSCs thatprovide emergency care and that areclosely associated with a CSC, which
provides more extensive care, hasconsiderable appeal. (Newrecommendation)

AHA/ASA ClassClass IIa: Benefit>>Risk

ICSI Work Group
Consensus
Qualification Statement/
Comment

Agree

IT IS REASONABLE toperform
procedure/administer
treatment.

Class IIa: Benefit>>Risk

New Literature
SupportDemaerschalk, 2012a;
Demaerschalk, 2012b;
Meyer, 2012Agree

IT IS REASONABLE toperform
procedure/administer
treatment.

Evaluation/Diagnosis
AHA/ASA Recommendation

AHA/ASA Class

Emergency Evaluation and Diagnosis of Acute Ischemic Stroke
1. An organized protocol for the
emergency evaluation of patients withsuspected stroke is recommended(Class I; Level of Evidence B). The goal
is to complete an evaluation and to
begin fibrinolytic treatment within 60
minutes of the patient’s arrival in an
ED. Designation of an acute stroke
team that includes physicians, nurses,
and laboratory/radiology personnel isencouraged. Patients with strokeshould have a careful clinicalassessment, including neurologicalexamination. (Unchanged from theprevious guideline)

Class I: Benefit>>>Risk

ICSI Work Group
Consensus

New Literature
Support

Qualification Statement/
Comment
Agree

Procedure/Treatment
SHOULD be
performed/administered.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

10Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

2. The use of a stroke rating scale,preferably the NIHSS, is
recommended (Class I; Level of
Evidence B). (Unchanged from theprevious guideline)

AHA/ASA ClassClass I: Benefit>>>Risk

ICSI Work Group
Consensus
Qualification Statement/
Comment

Agree

Procedure/Treatment
SHOULD be
performed/administered.

3. A limited number of hematologic,
coagulation, and biochemistry tests
are recommended during the initialemergency evaluation, and only theassessment of blood glucose must
precede the initiation of intravenous
rtPA (Table 8) (Class I; Level of
Evidence B). (Revised from the previous
guideline)

Class I: Benefit>>>Risk

Agree

Procedure/Treatment
SHOULD be
performed/administered.

4. Baseline electrocardiogramassessment is recommended inpatients presenting with acuteischemic stroke but should not delay
initiation of intravenous rtPA (Class I;
Level of Evidence B). (Revised from theprevious guideline)

Class I: Benefit>>>Risk

For the list of tests, refer toTable 8 (Immediate
Diagnostic Studies:
Evaluation of a Patient With
Suspected Acute Ischemic
Stroke) on page 881 in the2013 AHA/ASA Guidelines
for the Early Management ofPatients with Acute Ischemic
Stroke.

5. Baseline troponin assessment isrecommended in patients presenting
with acute ischemic stroke but should
not delay initiation of intravenous
rtPA (Class I; Level of Evidence C).
(Revised from the previous guideline)

6. The usefulness of chest radiographs
in the hyperacute stroke setting in theabsence of evidence of acutepulmonary, cardiac, or pulmonary
vascular disease is unclear. If
obtained, they should notunnecessarily delay administration offibrinolysis (Class IIb; Level of
Evidence B). (Revised from the previous
guideline)

New Literature
Support

Agree

Procedure/Treatment
SHOULD be
performed/administered.

Class I: Benefit>>>Risk

Agree

Procedure/Treatment
SHOULD be
performed/administered.
Class IIb: Benefit ≥ Risk

Agree

Procedure/Treatment
MAY BECONSIDERED.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

11Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

AHA/ASA ClassICSI Work Group
Consensus

New Literature
Support

Qualification Statement/
Comment

Early Diagnosis: Brain and Vascular Imaging: Recommendations for Patients With Acute Cerebral Ischemic
Symptoms That Have Not Yet Resolved
1. Emergency imaging of the brain isrecommended before initiating any
specific therapy to treat acuteischemic stroke (Class I; Level of
Evidence A). In most instances, NECT
will provide the necessary information
to make decisions about emergency
management. (Unchanged from theprevious guideline)
2. Either NECT or MRI is
recommended before intravenous
rtPA administration to exclude ICH(absolute contraindication) and to
determine whether CT hypodensity or
MRI hyperintensity of ischemia ispresent (Class I; Level of Evidence A).
(Revised from the 2009 imaging
scientific statement)
3. Intravenous fibrinolytic therapy isrecommended in the setting of early
ischemic changes (other than frank
hypodensity) on CT, regardless of
their extent (Class I; Level of EvidenceA). (Revised from the 2009 imaging
scientific statement)

4. A non-invasive intracranial
vascular study is strongly
recommended during the initial
imaging evaluation of the acute stroke
patient if either intra-arterial
fibrinolysis or mechanicalthrombectomy is contemplated for
management but should not delay
intravenous rtPA if indicated (Class I;
Level of Evidence A). (Revised from the2009 imaging scientific statement)

Class I: Benefit>>>Risk

Agree

Procedure/Treatment
SHOULD be
performed/administered.

Class I: Benefit>>>Risk

Agree

Procedure/Treatment
SHOULD be
performed/administered.

Class I: Benefit>>>Risk

Agree

Procedure/Treatment
SHOULD be
performed/administered.

Class I: Benefit>>>Risk

Agree with qualification

Procedure/Treatment
SHOULD be
performed/administered.

The ICSI work group would
like to change thisrecommendation to add“cervical and” before
intracranial vascular.
Therefore, therecommendation would state
the following:
A non-invasive cervical andintracranial vascular study
is strongly recommended
during the initial imaging
evaluation of the acutestroke patient if either
intra-arterial fibrinolysis ormechanical thrombectomy
is contemplated for
management but should notdelay intravenous rtPA if
indicated.

Return to Table of Contents
Institute for Clinical Systems Improvement

Menon, 2015;
van den Wijngaard,
2015;
Chung, 2014www.icsi.org
12Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

5. In intravenous fibrinolysis
candidates, the brain imaging study
should be interpreted within 45
minutes of patient arrival in the ED bya physician with expertise in reading
CT and MRI studies of the brain
parenchyma (Class I; Level of
Evidence C). (Revised from the previous
guideline)

AHA/ASA ClassClass I: Benefit>>>Risk

ICSI Work Group Consensus
Qualification Statement/
Comment

Agree

Spokoyny, 2014;
Demaerschalk,
2012b

Albers, 2015;
Borst, 2015;
Burton, 2015;
Galinovic, 2014;
Sanelli, 2014;
Schroeder, 2014;
Lin, 2014;
Kidwell, 2013;
Michel, 2012;
Nagakane, 2012

Procedure/Treatment
SHOULD be
performed/administered.

6. CT perfusion and MRI perfusionand diffusion imaging, including
measures of infarct core andpenumbra, may be considered for theselection of patients for acutereperfusion therapy beyond the time
windows for intravenous fibrinolysis.
These techniques provide additional
information that may improve
diagnosis, mechanism, and severity ofischemic stroke and allow more
informed clinical decision-making(Class IIb; Level of Evidence B).
(Revised from the 2009 imaging
scientific statement)

Class IIb: Benefit ≥ Risk

Disagree

Procedure/Treatment
MAY BECONSIDERED

7. Frank hypodensity on NECT may
increase the risk of hemorrhage withfibrinolysis and should be consideredin treatment decisions. If frank
hypodensity involves more than one
third of the MCA territory,
intravenous rtPA treatment should be
withheld (Class III; Level of EvidenceA). (Revised from the 2009 imaging
scientific statement)

Class III: Harm or No
Benefit

The ICSI Diagnosis and Initial
Treatment of Ischemic Stroke
work group concluded that
evidence of value ofcore/penumbra imaging remains
unproven, and its use in
selecting patients for treatment
with IV tPA beyond
recommended time window of
4.5 hours from onset is notrecommended outside aclinical trial per
recommendation 3 in Wakeup/Unclear Onset Time Stroke
section of Intravenous
Fibrinolysis recommendations
table. Recommendation 3
pertains to the use of imaging
criteria to determine
administration of IV tPA but inthe setting of “wake-up stroke”(or onset time unknown). Pleasealso see recommendation 3 inImaging section of EndovascularInterventions recommendations
table pertaining to selection forendovascular thrombectomy
beyond recommended windowof 6 hours from onset.

Return to Table of Contents
Institute for Clinical Systems Improvement

New Literature
SupportAgree

www.icsi.org
13

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations

Acute Management
AHA/ASA Recommendation

AHA/ASA ClassICSI Work Group Consensus

General Supportive Care and Treatment of Acute Complications
1. Cardiac monitoring is recommended
to screen for atrial fibrillation and otherpotentially serious cardiac arrhythmiasthat would necessitate emergency cardiac
interventions. Cardiac monitoring shouldbe performed for at least the first 24
hours (Class I; Level of Evidence B).
(Revised from the previous guideline)

Class I:
Benefit>>>Risk

2. Patients who have elevated bloodpressure and are otherwise eligible fortreatment with intravenous rtPA shouldhave their blood pressure carefully
lowered (Table 9) so that their systolicblood pressure is <185 mmHg and theirdiastolic blood pressure is <110 mmHg
(Class I; Level of Evidence B) before
fibrinolytic therapy is initiated. If
medications are given to lower bloodpressure, the clinician should be sure thatthe blood pressure is stabilized at thelower level before beginning treatment
with intravenous rtPA and maintained
below 180/105 mmHg for at least the first
24 hours after intravenous rtPA
treatment. (Unchanged from the previous
guideline)

Class I:
Benefit>>>Risk

3. Airway support and ventilatory
assistance are recommended for thetreatment of patients with acute stroke
who have decreased consciousness or who
have bulbar dysfunction that causes
compromise of the airway (Class I; Levelof Evidence C). (Unchanged from theprevious guideline)
4. Supplemental oxygen should be
provided to maintain oxygen saturation >94% (Class I; Level of Evidence C).
(Revised from the previous guideline)

Procedure/Treatment
SHOULD be performed/
administered.

Procedure/Treatment
SHOULD be performed/
administered.

Class I:
Benefit>>>Risk

Qualification Statement/
Comment

New Literature
SupportAgree

Further studies are required todetermine patient selection,
optimal timing, method andduration of cardiac
monitoring, which areimportant issues relevant tolong-term secondary stroke
prevention that is beyond thepurview of this guideline.
Agree
For approaches to arterial
hypertension in acute ischemic
stroke, refer to Table 9(Potential Approaches toArterial Hypertension in Acute
Ischemic Stroke Patients Who
are Candidates for Acute
Reperfusion Therapy) on page
891 in the 2013 AHA/ASA
Guidelines for the EarlyManagement of Patients with
Acute Ischemic Stroke.

Berge, 2015;
Lee, 2015;
Bath, 2014;He, 2014

Agree

Minnerup, 2012

Agree

Bennett, 2014

Procedure/Treatment
SHOULD be
performed/administered.

Class I:
Benefit>>>Risk
Procedure/Treatment
SHOULD be
performed/administered.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

14Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

5. Sources of hyperthermia (temperature> 38°C) should be identified and treated,
and antipyretic medications should be
administered to lower temperature in
hyperthermic patients with stroke (ClassI; Level of Evidence C). (Unchanged fromthe previous guideline)
6. Until other data become available,
consensus exists that the previously
described blood pressure
recommendations should be followed inpatients undergoing other acuteinterventions to recanalize occluded
vessels, including intra-arterial
fibrinolysis (Class I; Level of Evidence C).
(Unchanged from the previous guideline)

7. In patients with markedly elevatedblood pressure who do not receive
fibrinolysis, a reasonable goal is to lower
blood pressure by 15% during the first 24
hours after onset of stroke. The level ofblood pressure that would mandate suchtreatment is not known, but consensus
exists that medications should be
withheld unless the systolic bloodpressure is > 220 mm Hg or the diastolicblood pressure is > 120 mm Hg (Class I;
Level of Evidence C). (Revised from theprevious guideline)
8. Hypovolemia should be corrected withintravenous normal saline, and cardiac
arrhythmias that might be reducing
cardiac output should be corrected (ClassI; Level of Evidence C). (Revised from theprevious guideline)

AHA/ASA ClassClass I:
Benefit>>>Risk

ICSI Work Group
Consensus

New Literature
Support

Qualification Statement/
Comment

Agree

Procedure/Treatment
SHOULD be
performed/administered.
Class I:
Benefit>>>Risk
Procedure/Treatment
SHOULD be
performed/administered.

Class I:
Benefit>>>Risk

Agree with qualification
For the list of therapies, refer
to Table 9 (Potential
Approaches to Arterial
Hypertension in Acute
Ischemic Stroke Patients Who
are Candidates for Acute
Reperfusion Therapy) on page
891 in the 2013 AHA/ASA
Guidelines for the EarlyManagement of Patients with
Acute Ischemic Stroke
guideline.
It is consensus of the ICSI
work group to add Clevidipine
to this list. Studies have been
done to evaluate theeffectiveness and safety of thistherapy.
AgreeHe, 2014

Procedure/Treatment
SHOULD be
performed/administered.

Class I:
Benefit>>>Risk

Agree

Procedure/Treatment
SHOULD be
performed/administered.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

15

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

9. Hypoglycemia (blood glucose < 60
mg/dL) should be treated in patients withacute ischemic stroke (Class I; Level of
Evidence C). The goal is to achieve
normoglycemia. (Revised from theprevious guideline)

AHA/ASA ClassClass I:
Benefit>>>Risk

ICSI Work Group
Consensus

New Literature
Support

Qualification Statement/
Comment

Agree

Procedure/Treatment
SHOULD be
performed/administered.

10. Evidence from one clinical trial
indicates that initiation ofantihypertensive therapy within 24 hoursof stroke is relatively safe. Restarting
antihypertensive medications isreasonable after the first 24 hours forpatients who have preexisting
hypertension and are neurologicallystable unless a specific contraindication
to restarting treatment is known (Class
IIa; Level of Evidence B). (Revised fromthe previous guideline)

Class IIa:
Benefit>>Risk

11. No data are available to guideselection of medications for the loweringof blood pressure in the setting of acuteischemic stroke. The antihypertensive
medications and doses included in Table
9 are reasonable choices based on generalconsensus (Class IIa; Level of Evidence
C). (Revised from the previous guideline)

Class IIa:
Benefit>>Risk

IT IS REASONABLE
to perform
procedure/administer
treatment.

IT IS REASONABLE
to perform procedure/administer treatment.

Agree
As 2013 AHA/ASA guideline
for the Early Management ofPatients with Acute Ischemic
Stroke point out on p. 891, theoptimal time after onset ofischemic stroke to restart or
start long-term
antihypertensive therapy has
not been established. The
optimal time may depend on
patient and strokecharacteristics. It seems
reasonable to initiate longterm antihypertensive therapy
after the initial 24 hours fromstroke onset in most patients.
Agree with qualification

For the list of therapies, refer
to Table 9 (Potential
Approaches to Arterial
Hypertension in Acute
Ischemic Stroke Patients Who
are Candidates for Acute
Reperfusion Therapy) on page
891 in the 2013 AHA/ASA
Guidelines for the EarlyManagement of Patients with
Acute Ischemic Stroke.
It is consensus of the ICSI
work group to add Clevidipine
to this list. Studies have been
done to evaluate theeffectiveness and safety of thistherapy.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

16

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

12. Evidence indicates that persistent inhospital hyperglycemia during the first
24 hours after stroke is associated withworse outcomes than normoglycemia,
and thus, it is reasonable to treat
hyperglycemia to achieve blood glucose
levels in a range of 140 to 180 mg/dL andto closely monitor to prevent
hypoglycemia in patients with acuteischemic stroke (Class IIa; Level of
Evidence C). (Revised from the previous
guideline)

13. The management of arterial
hypertension in patients not undergoingreperfusion strategies remains
challenging. Data to guiderecommendations for treatment areinconclusive or conflicting. Many patients
have spontaneous declines in bloodpressure during the first 24 hours after
onset of stroke. Until more definitive data
are available, the benefit of treatingarterial hypertension in the setting ofacute ischemic stroke is not wellestablished (Class IIb; Level of Evidence
C). Patients who have malignant
hypertension or other medical indications
for aggressive treatment of bloodpressure should be treated accordingly.
(Revised from the previous guideline)

14. Supplemental oxygen is notrecommended in non-hypoxic patientswith acute ischemic stroke (Class III;
Level of Evidence B). (Unchanged from theprevious guideline)

AHA/ASA ClassClass IIa:
Benefit>>Risk

ICSI Work Group
Consensus

New Literature
Support

Qualification Statement/
Comment

Agree

Rosso, 2015

Agree

Lee, 2015;
Zhao, 2015;
Bath, 2014;He, 2014

Agree

Bennett, 2014

IT IS REASONABLE
to perform
procedure/administer
treatment.

Class IIb: Benefit ≥Risk
Procedure/Treatment
MAY BECONSIDERED.

Class III: Harm or No
Benefit

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

17

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

AHA/ASA ClassICSI Work Group
Consensus

New Literature
Support

Qualification Statement/
Comment

Intravenous Fibrinolysis (Endorsed Recommendations from the 2016 Scientific Rationale for the Inclusion
and Exclusion Criteria for Intravenous Alteplase in Acute Ischemic Stroke)
Age Issues

1. For otherwise medically eligible
patients ≥ 18 years of age, intravenous
alteplase administration within 3 hours isequally recommended for patients < 80
and > 80 years of age. Older age is anadverse prognostic factor in stroke but
does not modify the treatment effect ofthrombolysis. Although older patients
have poorer outcomes, higher mortality,and higher rates of sICH than those < 80years of age, compared with control
subjects, intravenous alteplase provides abetter chance of being independent at 3
months across all age groups (Class I;
Level of Evidence A).

Class I:
Benefit>>>Risk

2. The efficacy and risk of intravenous
alteplase administration in the pediatricpopulation (neonates, children, andadolescents < 18 years of age) are not wellestablished (Class IIb; Level of Evidence
B).

Class IIb: Benefit ≥Risk

1. For severe stroke symptoms,
intravenous alteplase is indicated within 3
hours from symptom onset of ischemic
stroke. Despite increased risk ofhemorrhagic transformation, there is stillproven clinical benefit for patients withsevere stroke symptoms (Class I; Level of
Evidence A).

Class I:
Benefit>>>Risk

Stroke Severity

2. For patients with mild but disabling
stroke symp"toms, intravenous alteplase isindicated within 3 hours from symptom
onset of ischemic stroke. There should be
no exclusion for patients with mild but
nonetheless disabling stroke symptoms in
the opinion of the treating physician fromtreatment with intravenous alteplase
because there is proven clinical benefit
for those patients (Class I; Level of
Evidence A).

Agree

Procedure/Treatment
SHOULD be performed/
administered.

Agree

Procedure/Treatment
MAY BECONSIDERED.
Agree

Procedure/Treatment
SHOULD be
performed/administered.

Class I:
Benefit>>>Risk

Agree

Procedure/Treatment
SHOULD be
performed/administered.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

18

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

AHA/ASA Class

3. Within 3 hours from symptom onset,
treatment of patients with milder
ischemic stroke symptoms that are
judged as non-disabling may beconsidered. Treatment risks should beweighed against possible benefits;
however, more study is needed to further
define the risk-to-benefit ratio (Class IIb;
Level of Evidence C).

Class IIb: Benefit >Risk

1. Intravenous alteplase treatment isreasonable for patients who present withmoderate to severe ischemic stroke anddemonstrate early improvement but
remain moderately impaired andpotentially disabled in the judgment of
the examiner (Class IIa; Level of Evidence
A).

Class IIa:
Benefit>>Risk

Rapidly Improving

ICSI Work Group
Consensus
Qualification Statement/
Comment

Agree

Procedure/Treatment
MAY BECONSIDERED.

Agree

IT IS REASONABLE
to perform
procedure/administer
treatment.

2. Because time from onset of symptoms
to treatment has such a powerful impact
on outcome, delaying treatment withintravenous alteplase to monitor for
further improvement is notrecommended (Class III; Level of
Evidence C).

Class III: Harm or No
BenefitAgree

1. The time from last seen normal totreatment with intravenous alteplaseshould be < 3 hours for eligible patientswith the use of standard eligibility
criteria (Class I; Level of Evidence A).

Class I:
Benefit>>>Risk

Agree

2. Intravenous alteplase treatment in the
3- to 4.5-hour time window is also
recommended for those patients < 80years of age without a history of bothdiabetes mellitus and prior stroke, NIHSS
score < 25, not taking any OACs, andwithout imaging evidence of ischemic
injury involving more than one third of
the MCA territory (Class I; Level of
Evidence B).

Class I:
Benefit>>>Risk

Time from Symptom Onset

3. Treatment should be initiated as
quickly as possible within the above listed
time frames because time to treatment isstrongly associated with outcome (Class I;
Level of Evidence A).

Return to Table of Contents
Institute for Clinical Systems Improvement

New Literature
Support

Procedure/Treatment
SHOULD be
performed/administered.

Procedure/Treatment
SHOULD be
performed/administered.

Class I:
Benefit>>>Risk

Agree
See Extended 3- to 4.5-Hour
Window: Recommendations
Section below forrecommendations on patients> 80 years of age, patientstaking warfarin with an INR <1.7, patients with a baseline
NIHSS score > 25 and patientswith prior stroke and diabetes
mellitus.
Agree

Procedure/Treatment
SHOULD be
performed/administered.

www.icsi.org
19

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

AHA/ASA ClassICSI Work Group
Consensus
Qualification Statement/
Comment

4. In patients in the 0- to 4.5-hour time
window who meet criteria for treatment
with intravenous alteplase, substantiallydelaying intravenous alteplase treatment
to obtain penumbral imaging before
treatment is not recommended (Class III;
Level of Evidence C).

Class III: Harm or No
BenefitAgree

1. Intravenous alteplase is recommended
for carefully selected patients who meet
ECASS III criteria and are treated in the
3- to 4.5-hour window (Class I; Level of
Evidence B).

Class I:
Benefit>>>Risk

Agree

2. For patients > 80 years of age
presenting in the 3- to 4.5-hour window,
intravenous alteplase treatment is safe
and can be as effective as in younger
patients (Class IIa; Level of Evidence B).

Class IIa:
Benefit>>Risk

Extended 3- to 4.5-Hour Window

Procedure/Treatment
SHOULD be
performed/administered.

Class IIb: Benefit ≥Risk

4. The benefit of intravenous alteplaseadministration for acute stroke patientswith a baseline NIHSS score > 25 andpresenting in the 3- to 4.5-hour window isuncertain (Class IIb; Level of Evidence C).

Class IIb: Benefit ≥Risk

Acute Intracranial Hemorrhage on CT

1. Intravenous alteplase should not be
administered to a patient whose CT
reveals an acute intracranial hemorrhage(Class III; Level of Evidence C).

Agree

IT IS REASONABLE
to perform
procedure/administer
treatment.

3. For patients taking warfarin and withan INR < 1.7 who present in the 3- to 4.5hour window, intravenous alteplasetreatment appears safe and may bebeneficial (Class IIb; Level of Evidence B).

5. In acute ischemic stroke patients withprior stroke and diabetes mellitus
presenting in the 3- to 4.5- hour window,
intravenous alteplase may be as effective
as treatment in the 0- to 3-hour window
and may be a reasonable option (Class
IIb; Level of Evidence B).

New Literature
Support

Procedure/Treatment
MAY BECONSIDERED.

Procedure/Treatment
MAY BECONSIDERED.
Class IIb: Benefit ≥
Risk

Agree

Agree

Agree

Procedure/Treatment
MAY BECONSIDERED.

Class III: Harm or No
Benefit

Agree

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

20Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

Pregnancy and Postpartum

1. Intravenous alteplase administration
for ischemic stroke may be considered in
pregnancy when the anticipated benefitsof treating moderate to severe stroke
outweigh the anticipated increased risks
of uterine bleeding (Class IIb; Level of
Evidence C).

AHA/ASA ClassClass IIb: Benefit ≥Risk
Procedure/Treatment
MAY BECONSIDERED.
Class IIb: Benefit ≥Risk

3. Urgent consultation with anobstetrician-gynecologist and potentiallya perinatologist to assist withmanagement of the mother and fetus isrecommended (Class I; Level of Evidence
C).

Class I:
Benefit>>>Risk

Procedure/Treatment
MAY BECONSIDERED.

Agree with qualification
It is consensus of the ICSI
work group to recommend
consultation with a high-risk
obstetrics gynecology provider
in these instances.
Agree

Agree

Procedure/Treatment
SHOULD be
performed/administered.

1. The safety and efficacy of intravenous
alteplase for acute stroke patients withClass III: Harm or No
BenefitAgree

2. Given the extremely low risk of
unsuspected abnormal platelet counts or
coagulation studies in a population, it isreasonable that urgent intravenous
alteplase treatment not be delayed while
waiting for hematologic or coagulation
testing if there is no reason to suspect anabnormal test (Class IIa; Level of
Evidence B).

Class IIa:
Benefit>>Risk

Agree

1. The safety and efficacy of intravenous
alteplase for acute stroke patients with aclinical history of potential bleeding
diathesis or coagulopathy are unknown.
Intravenous alteplase may be consideredon a case-by-case basis (Class IIb; Level of
Evidence C).

Class IIb: Benefit ≥Risk

3

platelets < 100000/mm , INR > 1.7, aPTT
> 40 seconds, or PT > 15 seconds are
unknown, and intravenous alteplase is
not recommended (Class III; Level of
Evidence C).

New Literature
Support

Qualification Statement/
Comment

2. The safety and efficacy of intravenous
alteplase in the early postpartum period(< 14 days after delivery) have not been
well established (Class IIb; Level of
Evidence C).

Platelets and Coagulation Studies

ICSI Work Group
Consensus

IT IS REASONABLE
to perform
procedure/administer
treatment.

History of Bleeding Diathesis/Coagulopathy

Agree

Procedure/Treatment
MAY BECONSIDERED.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

21

Recommendations
AHA/ASA Recommendation

Anticoagulant Use

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

AHA/ASA ClassICSI Work Group Consensus
Qualification Statement/
Comment
Agree

1. Intravenous alteplase may be reasonablein patients who have a history of warfarin
use and an INR ≤ 1.7 (Class IIb; Level of
Evidence B).

Class IIb: Benefit ≥Risk

2. Intravenous alteplase in patients who
have a history of warfarin use and an INR >1.7 is not recommended (Class III; Level of
Evidence B).

Class III: Harm or
No Benefit

Agree

3. Intravenous alteplase in patients who
have received a dose of LMWH within theprevious 24 hours is not recommended. Thisapplies to both prophylactic doses andtreatment doses (Class III; Level of Evidence
B).

Class III: Harm or
No Benefit

Agree

4. The use of intravenous alteplase inpatients taking direct thrombin inhibitors ordirect factor Xa inhibitors has not been
firmly established but may be harmful (Class
III; Level of Evidence C). The use of
intravenous alteplase in patients taking
direct thrombin inhibitors or direct factor
Xa inhibitors is not recommended unlesslaboratory tests such as aPTT, INR, platelet
count, ecarin clotting time, thrombin time,
or appropriate direct factor Xa activity
assays are normal or the patient has notreceived a dose of these agents for > 48 hours(assuming normal renal metabolizing
function).

Class III: Harm or
No Benefit

Agree

Procedure/Treatment
MAY BECONSIDERED.

New
Literature
Support

Refer to Table 4 (Inclusion andExclusion Characteristics ofPatients With Ischemic Stroke
Who Could Be Treated With
Intravenous rTPA Within 3 Hours
From Symptom Onset) on page586 of the 2016 Scientific
Rationale for the Inclusion andExclusion Criteria for Intravenous
Alteplase in Acute Ischemic
Stroke. The table states that as it
relates to heparin, exclusion
criteria include heparin
received within 48 hours resulting
in abnormally elevated aPTT
above the upper limit of normal.
Antidotes are being tested for
direct factor Xa and thrombin
inhibitors. At this point, no
recommendation can be madeabout efficacy and safety ofalteplase in patients taking direct
facor Xa and thrombin inhibitors.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

22Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

Major Surgery Within 14 Days

AHA/ASA ClassICSI Work Group
Consensus

New Literature
Support

Qualification Statement/
Comment

1. Use of intravenous alteplase in
carefully selected patients presenting withacute ischemic stroke who haveundergone a major surgery in thepreceding 14 days may be considered, but
the potential increased risk of surgicalsite hemorrhage should be weighedagainst the anticipated benefits ofreduced stroke-related neurologicaldeficits (Class IIb; Level of Evidence C).

Class IIb: Benefit ≥Risk

2. In acute ischemic stroke patients withrecent severe head trauma (within 3months), intravenous alteplase iscontraindicated (Class III; Level of
Evidence C).

Class III: Harm or No
BenefitAgree

3. Given the possibility of bleeding
complications from the underlying severe
head trauma, intravenous alteplase is notrecommended in posttraumatic infarctionthat occurs during the acute in-hospitalphase (Class III; Level of Evidence C).

Class III: Harm or No
BenefitAgree

1. For patients presenting withconcurrent acute ischemic stroke andacute MI, treatment with intravenous
alteplase at the dose appropriate for
cerebral ischemia, followed by
percutaneous coronary angioplasty andstenting if indicated, is reasonable (Class
IIa; Level of Evidence C).

Class IIa:
Benefit>>Risk

Agree

Agree

Procedure/Treatment
MAY BECONSIDERED.

Major Trauma Within 14 days and Severe Head Trauma Within 3 Months
Agree
1. In acute ischemic stroke patients withClass IIb: Benefit ≥recent major trauma (within 14 days),Risk
intravenous alteplase may be carefully
Procedure/Treatment
considered, with the risks of bleeding
MAY BE
from injuries related to the trauma
CONSIDERED.
weighed against the severity and potential
disability from the ischemic stroke (Class
IIb; Level of Evidence C).

Acute MI or History of Recent MI

IT IS REASONABLE
to perform
procedure/administer
treatment.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

23

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

AHA/ASA Class

2. For patients presenting with acuteischemic stroke and a history of recent
MI in the past 3 months, treating theischemic stroke with intravenous
alteplase is reasonable if the recent MI
was non-STEMI (Class IIa; Level of
Evidence C), is reasonable if the recent
MI was STEMI involving the right orinferior myocardium (Class IIa; Level of
Evidence C), and may be reasonable if therecent MI was STEMI involving the left
anterior myocardium (Class IIb; Level of
Evidence C).

Class IIa:
Benefit>>Risk

1. For patients with major acute ischemic
stroke likely to produce severe disability
and known left atrial or ventricularthrombus, treatment with intravenous
alteplase may be reasonable (Class IIb;
Level of Evidence C).

Class IIb: Benefit ≥Risk

Left-Sided Heart Thrombus

New Literature
Support

Qualification Statement/
Comment

Agree

IT IS REASONABLE
to perform
procedure/administer
treatment.
Class IIb: Benefit ≥Risk
Procedure/Treatment
MAY BECONSIDERED.
Agree

Procedure/Treatment
MAY BECONSIDERED.

2. For patients presenting with moderateacute ischemic stroke likely to produce
mild disability and known left atrial or
ventricular thrombus, treatment withintravenous alteplase is of uncertain net
benefit (Class IIb; Level of Evidence C).

Class IIb: Benefit ≥Risk

1. For patients with acute ischemic
stroke and symptoms consistent with
infective endocarditis, treatment withintravenous alteplase is not recommended
because of the increased risk of
intracranial hemorrhage (Class III; Levelof Evidence C).

Class III: Harm or No
Benefit

1. For patients with acute ischemic
stroke and a history of intracranial/spinal
surgery within the prior 3 months,
intravenous alteplase is potentiallyharmful (Class III; Level of Evidence C).

Class III: Harm or No
BenefitEndocarditis

ICSI Work Group
Consensus

Agree

Procedure/Treatment
MAY BECONSIDERED.

History of Intracranial/Spinal Surgery Within 3 Months

Agree

Agree

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

24

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

ICSI Work Group
Consensus

AHA/ASA Class

History of Ischemic Stroke Within 3 Months

Qualification Statement/
Comment

1. Use of intravenous alteplase in patients
presenting with acute ischemic stroke
who have had a prior ischemic stroke
within 3 months may be harmful (Class
III; Level of Evidence B).

Class III: Harm or No
BenefitAgree

2. The potential for increased risk ofsICH and associated morbidity andmortality exists but is not well established(Class IIb; Level of Evidence B).

Class IIb: Benefit ≥
Risk

Agree

3. The potential risks should be discussed
during thrombolysis eligibility
deliberation and weighed against the
anticipated benefits during decisionmaking (Class I; Level of Evidence C).

Class I:
Benefit>>>Risk

Procedure/Treatment
MAY BECONSIDERED.

New Literature
Support

Agree

Procedure/Treatment
SHOULD be
performed/administered.

Active Internal Bleeding or History of Gastrointestinal/Genitourinary Bleeding Within 21 Days
1. Reported literature details a low
bleeding risk with intravenous alteplaseadministration in the setting of past
gastrointestinal/genitourinary bleeding.
Administration of intravenous alteplasein this patient population may bereasonable (Class IIb; Level of Evidence
C).

Class IIb: Benefit ≥
Risk

Agree

Procedure/Treatment
MAY BECONSIDERED.

2. Patients with a structural
gastrointestinal malignancy or recent
bleeding event within 21 days of theirstroke event should be considered highrisk, and intravenous alteplaseadministration is potentially harmful(Class III; Level of Evidence C).

Class III: Harm or No
Benefit

1. The safety and efficacy ofadministering intravenous alteplase toacute stroke patients who have had anarterial puncture of a non-compressible
blood vessel in the 7 days preceding
stroke symptoms are uncertain (Class
IIb; Level of Evidence C).

Class IIb: Benefit ≥
Risk

Agree

Arterial Puncture of Non-Compressible Vessels in the Preceding 7 Days

Agree

Procedure/Treatment
MAY BECONSIDERED.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

25

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

AHA/ASA ClassICSI Work Group
Consensus

New Literature
Support

Qualification Statement/
Comment

Uncontrolled Hypertension, Severe Hypertension, Repeated Blood Pressure, or Requiring Aggressive Treatment
1. Intravenous alteplase is recommendedin patients whose blood pressure can belowered safely (to <185/110 mm Hg) withantihypertensive agents, with thephysician assessing the stability of theblood pressure before starting
intravenous alteplase (Class I; Level of
Evidence B).

Class I:
Benefit>>>Risk

Agree

Procedure/Treatment
SHOULD be
performed/administered.

2. If medications are given to lower bloodpressure, the clinician should be sure thatthe blood pressure is stabilized at thelower level before beginning treatment
with intravenous alteplase andmaintained below 180/105 mmHg for atleast the first 24 hours after intravenous
alteplase treatment (Class I; Level of
Evidence B).

Class I:
Benefit>>>Risk

1. Intravenous alteplase has not beenshown to increase sICH rates in patientswith CMBs. Intravenous alteplaseadministration in these patients istherefore reasonable (Class IIa; Level of
Evidence B).

Class IIa:
Benefit>>Risk

2. Intravenous alteplase administrationin patients who have a history of
intracranial hemorrhage is potentiallyharmful (Class III; Level of Evidence C).

Class III: Harm or No
Benefit

AgreeClass IIa:
Benefit>>Risk

Agree

History of Intracranial Hemorrhage

Unruptured Intracranial Aneurysm

1. For patients presenting with acuteischemic stroke who are known to harbora small or moderate-sized (< 10 mm)
unruptured and unsecured intracranial
aneurysm, administration of intravenous
alteplase is reasonable and probably
recommended (Class IIa; Level of
Evidence C).
2. Usefulness and risk of intravenous
alteplase in patients with acute ischemic
stroke who harbor a giant unruptured
and unsecured intracranial aneurysm are
not well established (Class IIb; Level of
Evidence C).

AgreeProcedure/Treatment
SHOULD be
performed/administered.

IT IS REASONABLE
to perform
procedure/administer
treatment.

Agree
CMB = Cerebral Microbleed

IT IS REASONABLE
to perform
procedure/administer
treatment.
Class IIb: Benefit ≥
Risk

Agree

Procedure/Treatment
MAY BECONSIDERED.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

26

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

Intracranial Vascular Malformation

1. For patients presenting with acuteischemic stroke who are known to harbor
an unruptured and untreatedintracranial vascular malformation, theusefulness and risks of administration of
intravenous alteplase are not wellestablished (Class IIb; Level of EvidenceC).

AHA/ASA ClassICSI Work Group
Consensus
Qualification Statement/
Comment

Class IIb: Benefit ≥
Risk

Agree

Procedure/Treatment
MAY BECONSIDERED.

2. Because of the increased risk of ICH in
this population of patients, intravenous
alteplase may be considered in patientswith stroke with severe neurologic
deficits and a high likelihood of morbidity
and mortality to outweigh the anticipatedrisk of ICH secondary to thrombolysis(Class IIb; Level of Evidence C).

Class IIb: Benefit ≥Risk

1. Intravenous alteplase treatment isprobably recommended for patients withacute ischemic stroke who harbor an
extra-axial intracranial neoplasm (Class
IIa; Level of Evidence C).

Class IIa:
Benefit>>Risk

2. Intravenous alteplase treatment forpatients with acute ischemic stroke who
harbor an intra-axial intracranial
neoplasm is potentially harmful (Class
III; Level of Evidence C).

Class III: Harm or No
Benefit

AgreeClass I:
Benefit>>>Risk

Agree

Intracranial Neoplasms

Serious Medical Comorbid Illnesses

1. In patients with end-stage renal
disease on hemodialysis and normal
aPTT, intravenous alteplase isrecommended (Class I; Level of Evidence
C). However, those with elevated aPTT
may have elevated risk for hemorrhagic
complications.
2. Patients with preexisting dementia
may benefit from intravenous alteplase(Class IIb; Level of Evidence B).
Individual considerations such as life
expectancy and premorbid level offunction are important to determine
whether alteplase may offer a clinicallymeaningful benefit.

Return to Table of Contents
Institute for Clinical Systems Improvement

New Literature
Support

Agree

Procedure/Treatment
MAY BECONSIDERED.

IT IS REASONABLE
to perform
procedure/administer
treatment.

Agree

Procedure/Treatment
SHOULD be
performed/administered.
Class IIb: Benefit ≥
Risk

Agree

Procedure/Treatment
MAY BECONSIDERED.

www.icsi.org
27

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

AHA/ASA ClassICSI Work Group
Consensus
Qualification Statement/
Comment

3. The safety and efficacy of alteplase inpatients with current malignancy are notwell established (Class IIb; Level of
Evidence C). Patients with systemic
malignancy and reasonable (> 6 months)
life expectancy may benefit fromintravenous alteplase if othercontraindications such as coagulation
abnormalities, recent surgery, or systemic
bleeding do not coexist.

Class IIb: Benefit ≥Risk

1. Preexisting disability does not seem toindependently increase the risk of sICH
after intravenous alteplase, but it may be
associated with less neurologicalimprovement and higher mortality.
Thrombolytic therapy with intravenous
alteplase for acute stroke patients withpreexisting disability (mRS score ≥ 2) may
be reasonable, but decisions should take
into account relevant factors other thanmRS (including quality of life, social
support, place of residence, need for a
caregiver after alteplase administration,
patients’ and families’ preferences, andgoals of care) (Class IIb; Level of Evidence
B).

Class IIb: Benefit ≥Risk

1. Intravenous alteplase is recommended inotherwise eligible patients within initial
glucose levels > 50 mg/ dL (Class I; Level of
Evidence A).

Class I:
Benefit>>>Risk

2. Treating clinicians should be aware thathypoglycemia and hyperglycemia may
mimic acute stroke presentations and checkblood glucose levels before intravenous
initiation. Intravenous alteplase is notindicated for nonvascular conditions (Class
III; Level of Evidence B).

Class III: Harm or No
Benefit

AgreeClass IIb: Benefit ≥
Risk

Agree

Preexisting Disability

Blood Glucose

3. Treatment with intravenous alteplase inpatients with acute ischemic stroke who
present with initial glucose levels > 400
mg/dL that are subsequently normalized
and who are otherwise eligible may bereasonable (Class IIb; Level of Evidence C).

Return to Table of Contents
Institute for Clinical Systems Improvement

New Literature
Support

Agree

Procedure/Treatment
MAY BECONSIDERED.

Agree

Procedure/Treatment
MAY BECONSIDERED.

Procedure/Treatment
SHOULD be
performed/administered.

Agree

Procedure/Treatment
MAY BECONSIDERED.

www.icsi.org
28

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

Seizure at Stroke Onset Syndrome

1. Intravenous alteplase is reasonable inpatients with a seizure at the time of onsetof acute stroke if evidence suggests that
residual impairments are secondary to
stroke and not a postictal phenomenon(Class IIa; Level of Evidence C).

Early Ischemic Changes on CT

AHA/ASA ClassICSI Work Group
Consensus

New Literature
Support

Qualification Statement/
Comment
Class IIa:
Benefit>>Risk

Agree

IT IS REASONABLE
to perform
procedure/administer
treatment.

1. Intravenous alteplase administration isrecommended in the setting of EICs ofmild to moderate extent (other than frank
hypodensity) (Class I; Level of Evidence
A).

Class I:
Benefit>>>Risk

2. There remains insufficient evidence toidentify a threshold of hypoattenuation
severity or extent that affects treatment
response to alteplase. However,administering intravenous alteplase topatients whose CT brain imaging exhibits
extensive regions of clear
hypoattenuation is not recommended.
These patients have a poor prognosis
despite intravenous alteplase, and severe
hypoattenuation defined as obvious
hypodensity represents irreversible
injury (Class III; Level of Evidence A).

Class III: Harm or No
Benefit

Procedure/Treatment
SHOULD be
performed/administered.

Agree

Agree

Diabetic Hemorrhagic Retinopathy or Other Hemorrhagic Ophthalmological Conditions
1. Use of intravenous alteplase in patients
presenting with acute ischemic stroke
who have a history of diabetic
hemorrhagic retinopathy or otherhemorrhagic ophthalmic conditions isreasonable to recommend, but thepotential increased risk of visual loss
should be weighed against the anticipatedbenefits of reduced stroke-related
neurological deficits (Class IIa; Level of
Evidence B).

Class IIa:
Benefit>>Risk

1. Intravenous alteplase iscontraindicated in patients presenting
with symptoms and signs most consistent
with an SAH (Class III; Level of Evidence
C).

Class III: Harm or No
BenefitAgree

IT IS REASONABLE
to perform
procedure/administer
treatment.

Suspicion of SAH on Pretreatment Evaluation

Agree

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

29

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

Wake-Up/Unclear Onset Time Stroke

AHA/ASA ClassICSI Work Group Consensus
Qualification Statement/
Comment

1. Intravenous alteplase is notrecommended in ischemic stroke
patients who awoke with stroke withtime last known to be at baseline state >3 or 4.5 hours (Class III; Level of
Evidence B).

Class III: Harm or
No Benefit

AgreeClass III: Harm or
No Benefit

Agree

3. Use of imaging criteria to selectischemic stroke patients who awoke withstroke or have unclear time of symptom
onset for treatment with intravenous
alteplase is not recommended outside aclinical trial (Class III; Level of Evidence
B).

Class III: Harm or
No Benefit

Agree with Qualification

Class IIa:
Benefit>>Risk

Agree

2. Intravenous alteplase is notrecommended in ischemic stroke
patients who have an unclear time and/or unwitnessed symptom onset and inwhom the time last known to be atbaseline state is > 3 or 4.5 hours (Class
III; Level of Evidence B).

Menstruation and Menorrhagia

1. Intravenous alteplase is probably
indicated in women who are
menstruating who present with acuteischemic stroke and do not have ahistory of menorrhagia. However,
women should be warned that alteplasetreatment could increase the degree of
menstrual flow (Class IIa; Level of
Evidence C).

Return to Table of Contents
Institute for Clinical Systems Improvement

New Literature
SupportThe ICSI Diagnosis and Initial
Treatment of Stroke work groupagrees with this recommendation.
Please also see recommendation 6
in “Early Diagnosis: Brain and
Vascular Imaging:
Recommendations for Patients
With Acute Cerebral Ischemic
Symptoms That Have Not Yet
Resolved” recommendations tablealso pertaining to IV tPA but in thesetting of patient selection fortreatment beyond therecommended window of 4.5 hours
from onset and recommendation 3
in “Imaging” section of“Endovascular Interventions”
recommendations table pertaining
to selection for endovascularthrombectomy beyond therecommended window of 6 hours
from onset.

IT IS
REASONABLE toperform
procedure/administer
treatment.

www.icsi.org
30

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

2. Because the potential benefits of
intravenous alteplase probably outweigh
the risks of serious bleeding in patientswith recent or active history ofmenorrhagia without clinically significant
anemia or hypotension, intravenous
alteplase administration may beconsidered (Class IIb; Level of EvidenceC).
3. When there is a history of recent or
active vaginal bleeding causing clinicallysignificant anemia, then emergent
consultation with a gynecologist is
probably indicated before a decision
about intravenous alteplase is made(Class IIa; Level of Evidence C).

AHA/ASA ClassClass IIb: Benefit ≥Risk

New Literature
Support

Qualification Statement/
Comment

Agree

Procedure/Treatment
MAY BECONSIDERED.

Class IIa:
Benefit>>Risk

Agree

IT IS REASONABLE
to perform
procedure/administer
treatment.

4. In patients who are menstruating or
have active vaginal bleeding and aretreated with alteplase, the degree ofvaginal bleeding should be monitored for
24 hours after alteplase (Class I; Level of
Evidence C).

Class I:
Benefit>>>Risk

1. For patients with major acute ischemic
stroke likely to produce severe disability
and cardiac myxoma, treatment withintravenous alteplase may be reasonable(Class IIb; Level of Evidence C).

Class IIb: Benefit ≥Risk

2. For patients presenting with major
acute ischemic stroke likely to produce
severe disability and papillary
fibroelastoma, treatment withintravenous alteplase may be reasonable(Class IIb; Level of Evidence C).

Class IIb: Benefit ≥RiskIntracardiac MassICSI Work Group
Consensus

Procedure/Treatment
SHOULD be
peformed/administered.

Procedure/Treatment
MAY BECONSIDERED.

Agree

Agree

Procedure/Treatment
MAY BECONSIDERED.

Aortic Arch Dissection and Cervicocephalic Arterial Dissection, Known or Suspected
1. Intravenous alteplase in acuteischemic stroke known or suspected to be
associated with aortic arch dissection is
not recommended and is potentiallyharmful (Class III; Level of Evidence C).
2. Intravenous alteplase in acuteischemic stroke known or suspected to be
associated with extracranial cervicalarterial dissection is reasonably safe
within 4.5 hours and is probably
recommended (Class IIa; Level of
Evidence C).

Return to Table of Contents
Institute for Clinical Systems Improvement

Class III: Harm or No
Benefit

AgreeClass IIa:
Benefit>>Risk

Agree

IT IS REASONABLE
to perform
procedure/administer
treatment.

www.icsi.org
31

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

AHA/ASA Class

3. Intravenous alteplase usefulness andhemorrhagic risk in acute ischemic stroke
known or suspected to be associated withintracranial arterial dissection remain
unknown, uncertain, and not wellestablished (Class IIb; Level of Evidence
C).

Class IIb: Benefit ≥Risk

1. Intravenous alteplase may beconsidered for patients who present withacute ischemic stroke, even in instances
when they may have undergone a lumbar
dural puncture in the preceding 7 days
(Class IIb; Level of Evidence C).

Class IIb: Benefit ≥Risk

1. The risk of symptomatic intracranial
hemorrhage in the SM population is quite
low; thus, starting intravenous alteplaseis probably recommended in preference
over delaying treatment to pursue
additional diagnostic studies (Class IIa;
Level of Evidence B).

Class IIa:
Benefit>>Risk

1. Intravenous alteplase is reasonable forthe treatment of acute ischemic stroke
complications of cardiac or cerebral
angiographic procedures, depending on
the usual eligibility criteria (Class IIa;
Level of Evidence A).

Class IIa:
Benefit>>Risk

Dural Puncture Within 7 Days

Psychogenic/Conversion/Malingering SM

ICSI Work Group
Consensus

New Literature
Support

Qualification Statement/
Comment

Agree

Procedure/Treatment
MAY BECONSIDERED.

Agree

Procedure/Treatment
MAY BECONSIDERED.
Agree

IT IS REASONABLE
to perform
procedure/administer
treatment.

Catheterization Laboratory Environment/ Endovascular Complications/Stroke Syndrome

Consent for the Incompetent Patient

1. In an emergency, when the patient is
not competent and there is no
immediately available legally authorized
representative to provide proxy consent,
it is recommended to proceed withintravenous alteplase in an otherwise
eligible patient with acute ischemic stroke(Class I; Level of Evidence C).
2. Visual displays that convey thebenefits and the risks of intravenous
alteplase can be useful to assist withshared decision making and aid inestablishing informed consent (Class IIa;
Level of Evidence B).

Return to Table of Contents
Institute for Clinical Systems Improvement

Agree

IT IS REASONABLE
to perform
procedure/administer
treatment.
Class I:
Benefit>>>Risk

Agree

Procedure/Treatment
SHOULD be
performed/administered.

Class IIa:
Benefit>>Risk

Agree

IT IS REASONABLE
to perform
procedure/administer
treatment.

www.icsi.org
32

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

Concurrent Antiplatelet Medication

AHA/ASA ClassICSI Work Group
Consensus
Qualification Statement/
Comment

1. The administration of aspirin (or otherantiplatelet agents) as an adjunctive
therapy within 24 hours of intravenous
alteplase is not recommended (Class III;
Level of Evidence C).

Class III: Harm or No
Benefit

AgreeClass III: Harm or No
BenefitAgree

3. Intravenous alteplase is recommended
for patients taking antiplatelet drug
monotherapy before stroke on the basisof evidence that the benefit of alteplaseoutweighs a possible small increased riskof sICH (Class I; Level of Evidence A).

Class I:
Benefit>>>Risk

Agree

2. The concurrent administration ofother intravenous antiplatelet agents that
inhibit the glycoprotein IIb/ IIIa receptor
is not recommended outside a clinical
trial (Class III; Level of Evidence B).

Procedure/Treatment
SHOULD be
performed/administered.

4. Intravenous alteplase is recommended
for patients taking antiplatelet drug
combination therapy (e.g., aspirin andclopidogrel) before stroke on the basis ofevidence that the benefit of alteplaseoutweighs a probable increased risk ofsICH (Class I; Level of Evidence B).

Class I:
Benefit>>>Risk

1. Treating clinicians should be awarethat illicit drug use may be a contributing
factor to incident stroke. Intravenous
alteplase is reasonable in instances ofillicit drug use–associated acute ischemic
stroke in patients with no otherexclusions (Class IIa; Level of Evidence
C).

Class IIa:
Benefit>>Risk

1. Acute management of ischemic stroke
resulting from SCD should include
optimal hydration, correction of
hypoxemia, correction of systemic
hypotension, and blood exchange toreduce the percentage of hemoglobin S
levels (Class I; Level of Evidence B).

Class I:
Benefit>>>Risk

Drug Use (Cocaine)

Sickle Cell Disease

2. Intravenous alteplase for children andadults presenting with an acute ischemic
stroke with known SCD is not wellestablished (Class IIb; Level of EvidenceC).

Return to Table of Contents
Institute for Clinical Systems Improvement

New Literature
Support

Agree

Procedure/Treatment
SHOULD be
performed/administered.

Agree

IT IS REASONABLE
to perform
procedure/administer
treatment.

Agree

Procedure/Treatment
SHOULD be
performed/administered.
Class IIb: Benefit ≥
Risk

Agree

Procedure/Treatment
MAY BECONSIDERED.

www.icsi.org
33

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

AHA/ASA ClassICSI Work Group
Consensus

New Literature
Support

Qualification Statement/
Comment

Endovascular Interventions (Recommendations from the 2015 American Heart Association/American Stroke
Association Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic
Stroke Regarding Endovascular Treatment)
Endovascular Interventions

1. Patients eligible for intravenous rtPAshould receive intravenous rtPA even if
endovascular treatments are being
considered (Class I; Level of Evidence A).
(Unchanged from the 2013 guideline)

Class I:
Benefit>>>Risk

2. Patients should receive endovasculartherapy with a stent retriever if they meet
all the following criteria (Class I; Level of
Evidence A). (New recommendation):a. Prestroke mRS score 0 to 1,b. Acute ischemic stroke receiving
intravenous rtPA within 4.5 hours of
onset according to guidelines fromprofessional medical societies,
c. Causative occlusion of the ICA or
proximal MCA (M1),!
d. Age ≥18 years,
e. NIHSS score of ≥6,!
f. ASPECTS of ≥6, andg. Treatment can be initiated (groinpuncture) within 6 hours

Class I:
Benefit>>>Risk

3. As with intravenous rtPA, reduced
time from symptom onset to reperfusion
with endovascular therapies is highly
associated with better clinical outcomes.
To ensure benefit, reperfusion to TICI
grade 2b/3 should be achieved as early as
possible and within 6 hours of stroke
onset (Class I; Level of Evidence B-R).
(Revised from the 2013 guideline)

4. When treatment is initiated beyond 6hours from symptom onset, theeffectiveness of endovascular therapy is
uncertain for patients with acute ischemic
stroke who have causative occlusion of
the ICA or proximal MCA (M1) (Class
IIb; Level of Evidence C). Additionalrandomized trial data are needed. (Newrecommendation)

Procedure/Treatment
SHOULD be
performed/administered.

Procedure/Treatment
SHOULD be
performed/administered.

Class I:
Benefit>>>Risk

Agree

Agree
The ICSI work group would
like to affirm that there is NO
upper age limit forendovascular stroke treatment
in acute ischemic stroke.
Elderly patients benefit
similarly to their younger
counterparts. Age should
never be solely used as
exclusion criteria forendovascular stroke treatment.

Agree

Procedure/Treatment
SHOULD be
performed/administered.

Class IIb: Benefit ≥
Risk

Agree

Procedure/Treatment
MAY BECONSIDERED.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

34

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

5. In carefully selected patients withanterior circulation occlusion who
have contraindications to
intravenous rtPA, endovasculartherapy with stent retrievers
completed within 6 hours of stroke
onset is reasonable (Class IIa; Levelof Evidence C). Inadequate data are
available at this time to determine
the clinical efficacy of endovasculartherapy with stent retrievers for
those patients whose
contraindications are time based or
not time based (e.g., prior stroke,
serious head trauma, hemorrhagic
coagulopathy, or receiving
anticoagulant medications). (Newrecommendation)

AHA/ASA Class

Upgraded Class:
Class I:
Benefit>>>Risk
Procedure/Treatment
SHOULD be
performed/administered.

6. Although the benefits are
uncertain, the use of endovasculartherapy with stent retrievers may bereasonable for carefully selectedpatients with acute ischemic strokein whom treatment can be initiated(groin puncture) within 6 hours ofsymptom onset and who havecausative occlusion of the M2 or M3
portion of the MCAs, anterior
cerebral arteries, vertebral arteries,
basilar artery, or posterior cerebral
arteries (Class IIb; Level of Evidence
C). (New recommendation)

Class IIb: Benefit ≥Risk

7. Endovascular therapy with stent
retrievers may be reasonable forsome patients < 18 years of age withacute ischemic stroke who havedemonstrated large-vessel occlusion
in whom treatment can be initiated(groin puncture) within 6 hours ofsymptom onset, but the benefits are
not established in this age group(Class IIb; Level of Evidence C).
(New recommendation)

Class IIb: Benefit ≥Risk

Procedure/Treatment
MAY BECONSIDERED.

ICSI Work Group Consensus
Qualification Statement/
Comment

Agree with qualification

New Literature
SupportGoyal, 2016

The ICSI work group recommends
that based upon the most recent trial
evidence, endovascular stroke
treatment should be pursued even inpatients with contraindications for IVtPA (Goyal, 2016). Therefore, theclass and level of evidence should be
upgraded to Class I, Level of
Evidence A.

Agree with qualification
The ICSI Diagnosis and Treatment ofIschemic Stroke guideline work groupagrees that it may be reasonable totreat causative occlusions in the M2
division of the MCA, anterior cerebral
artery, vertebral artery, basilar arteryor posterior cerebral artery (Goyal,
2016; Lemmens, 2016; Sarraj, 2016).

Goyal, 2016;
Lemmens, 2016;
Sarraj, 2016

Endovascular treatment of more distal
MCA occlusions such as the M3 or
M4 division is not wellstudied. Interventions on very distal
occlusions are less likely to result inclinical benefit than more proximal
occlusion (Lemmens, 2016). It isconsensus of the ICSI work group to
not recommend routine endovascularintervention of occlusion more distalthan the M2 division of the MCA.
Agree

Procedure/Treatment
MAY BECONSIDERED.

Return to Table of Contents
Institute for Clinical Systems Improvement

www.icsi.org
35

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

AHA/ASA ClassICSI Work Group
Consensus
Qualification Statement/
Comment

8. Although its benefits are uncertain,
the use of endovascular therapy withstent retrievers may be reasonable forpatients with acute ischemic stroke inwhom treatment can be initiated (groinpuncture) within 6 hours of symptom
onset and who have prestroke mRS score> 1, ASPECTS < 6, or NIHSS score < 6
and causative occlusion of the ICA or
proximal MCA (M1) (Class IIb; Level of
Evidence B-R). Additional randomized
trial data are needed. (Newrecommendation)

Class IIb: Benefit ≥RiskClass III: Harm or No
BenefitAgree

10. Use of stent retrievers is indicated in
preference to the MERCI device. (Class I;
Level of Evidence A).

Class I:
Benefit>>>RiskAgree

The use of mechanical thrombectomy
devices other than stent retrievers may bereasonable in some circumstances (Class
IIb, Level B-NR). (New recommendation)

Class IIb: Benefit ≥Risk

11. The use of a proximal balloon guidecatheter or a large-bore distal-accesscatheter rather than a cervical guidecatheter alone in conjunction with stent
retrievers may be beneficial (Class IIa;
Level of Evidence C). Future studies
should examine which systems provide
the highest recanalization rates with thelowest risk for non-target embolization.
(New recommendation)

Class IIa:
Benefit>>Risk

9. Observing patients after intravenous
rtPA to assess for clinical response before
pursuing endovascular therapy is not
required to achieve beneficial outcomes
and is not recommended. (Class III; Levelof Evidence B-R). (New recommendation)

New Literature
Support

Agree

Procedure/Treatment
MAY BECONSIDERED.

Procedure/Treatment
SHOULD be
performed/administered.

Procedure/Treatment
MAY BECONSIDERED.

Agree

IT IS REASONABLE
to perform
procedure/administer
treatment.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

36Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

12. The technical goal of thethrombectomy procedure should be a
TICI grade 2b/3 angiographic result tomaximize the probability of a goodfunctional clinical outcome (Class I; Levelof Evidence A). Use of salvage technicaladjuncts, including intra-arterial
fibrinolysis, may be reasonable to achievethese angiographic results if completed
within 6 hours of symptom onset (Class
IIb; Level of Evidence B-R). (Newrecommendation)

13. Angioplasty and stenting of proximal
cervical atherosclerotic stenosis orcomplete occlusion at the time ofthrombectomy may be considered, but
the usefulness is unknown (Class IIb;
Level of Evidence C). Future randomized
studies are needed. (New recommendation)
14. Initial treatment with intra-arterial
fibrinolysis is beneficial for carefully
selected patients with major ischemic
strokes of <6 hours’ duration caused by
occlusions of the MCA (Class I; Level of
Evidence B-R). However, these data arederived from clinical trials that no longer
reflect current practice, including the useof fibrinolytic drugs that are notavailable. A clinically beneficial dose of
intra-arterial rtPA is not established, andrtPA does not have US Food and Drug
Administration approval for intraarterial use. As a consequence,
endovascular therapy with stent
retrievers is recommended over intraarterial fibrinolysis as first-line therapy(Class I; Level of Evidence E). (Revised
from the 2013 guideline)

15. Intra-arterial fibrinolysis initiatedwithin 6 hours of stroke onset in carefully
selected patients who havecontraindications to the use of
intravenous rtPA might be considered,
but the consequences are unknown (Class
IIb; Level of Evidence C). (Revised fromthe 2013 guideline)

AHA/ASA ClassClass I:
Benefit>>>Risk

ICSI Work Group
Consensus

New Literature
Support

Qualification Statement/
Comment

Agree

Procedure/Treatment
SHOULD be
performed/administered.
Class IIb: Benefit ≥Risk
Procedure/Treatment
MAY BECONSIDERED.
Class IIb: Benefit ≥
Risk

Agree

Procedure/Treatment
MAY BECONSIDERED.
Class I:
Benefit>>>Risk

Agree

Procedure/Treatment
SHOULD be performed/
administered.

Class IIb: Benefit ≥
Risk

Agree

Procedure/Treatment
MAY BECONSIDERED.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

37

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

16. It might be reasonable to favor
conscious sedation over generalanesthesia during endovasculartherapy for acute ischemic stroke.
However, the ultimate selection ofanesthetic technique during
endovascular therapy for acuteischemic stroke should be
individualized on the basis ofpatient risk factors, tolerance ofthe procedure, and other clinicalcharacteristics. Randomized trial
data are needed (Class IIb; Level of
Evidence C). (New recommendation)

Imaging

1. Emergency imaging of the brain
is recommended before any specifictreatment for acute stroke isinitiated (Class I; Level of Evidence
A). In most instances, nonenhanced CT will provide thenecessary information to makedecisions about emergency
management. (Unchanged from the2013 guideline)

2. If endovascular therapy iscontemplated, a non-invasive
intracranial vascular study isstrongly recommended during theinitial imaging evaluation of theacute stroke patient but should notdelay intravenous rtPA if
indicated. For patients who qualify
for intravenous rtPA according to
guidelines from professional
medical societies, initiating
intravenous rtPA before
noninvasive vascular imaging is
recommended for patients who
have not had noninvasive vascularimaging as part of their initial
imaging assessment for stroke.
Noninvasive intracranial vascularimaging should then be obtained as
quickly as possible (Class I; Levelof Evidence A). (Newrecommendation)

AHA/ASA ClassClass IIb: Benefit ≥Risk
Procedure/Treatment
MAY BECONSIDERED.

Class I:
Benefit>>>Risk

ICSI Work Group Consensus
Qualification Statement/
Comment

New
Literature
SupportAgree with qualification

The ICSI Diagnosis and Initial Treatmentof Ischemic Stroke work group would
like to note that a recent randomized trial
by Schönenberger 2016 compared early
efficacy of endovascular thrombectomy
under general anesthesia vs. conscious
sedation and demonstrated no difference.
This was a small study, conducted at one
center, and was not powered for othersecondary outcomes such as mortality andfunctional status. Due to theselimitations, the ICSI Diagnosis and Initial
Treatment of Ischemic Stroke work groupwould like to emphasize that the choice ofintervention should be based on patientcharacteristics. Further research isneeded.
AgreeProcedure/Treatment
SHOULD be
performed/administered.

Class I:
Benefit>>>Risk
Procedure/Treatment
SHOULD be
performed/administered.

Return to Table of Contents
Institute for Clinical Systems Improvement

Agree with qualification
The ICSI work group recognizes thatclinical practice may vary. If an
institution’s initial imaging evaluation ofan acute stroke patient routinely includes
rapid, non-invasive vascular imaging that
does not delay administration of IV r-tPA,then it would be reasonable to obtainvascular imaging prior to administering
IV r-tPA. Conversely, there may beinstances where vascular imaging is notnecessary prior to initiating endovasculartreatment (e.g., presence of a hyperdense
vessel sign on non-contrast head CT, or
clinical syndrome of large vessel
occlusion stroke in the setting of a normal
head CT).

www.icsi.org
38

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

3. The benefits of additional imaging
beyond CT and CTA or MRI and MRAsuch as CT perfusion or diffusion- andperfusion-weighted imaging for selecting
patients for endovascular therapy are
unknown (Class IIb; Level of Evidence C).
Further randomized, controlled trials
may be helpful to determine whether
advanced imaging paradigms using CT
perfusion, CTA, and MRI perfusion anddiffusion imaging, including measures of
infarct core, collateral flow status, andpenumbra, are beneficial for selecting
patients for acute reperfusion therapy
who are within 6 hours of symptom onset
and have an ASPECTS < 6. Further
randomized, controlled trials should bedone to determine whether advanced
imaging paradigms with CT perfusion,
MRI perfusion, CTA, and diffusion
imaging, including measures of infarctcore, collateral flow status, andpenumbra, are beneficial for selecting
patients for acute reperfusion therapy
who are beyond 6 hours from symptom
onset. (New recommendation)

Stroke Systems of Care

1. Patients should be transported rapidly
to the closest available certified primarystroke center or comprehensive stroke
center or, if no such centers exist, themost appropriate institution thatprovides emergency stroke care as
described in the 2013 guidelines (Class I;
Level of Evidence A). In some instances,
this may involve air medical transportand hospital bypass. (Unchanged from the2013 guideline)

AHA/ASA ClassClass IIb: Benefit≥ RiskProcedure/Treatment
MAY BECONSIDERED.

Class I:
Benefit>>>Risk
Procedure/Treatment
SHOULD be performed/
administered.

ICSI Work Group
Consensus

New Literature
Support

Qualification Statement/
Comment

Agree with qualifications

The ICSI Diagnosis andTreatment of Ischemic Stroke
work group agrees with thisrecommendation. Please also
see recommendation 6 from
Early Diagnosis: Brain and
Vascular Imaging:
Recommendations for Patients
With Acute Cerebral Ischemic
Symptoms That Have Not Yet
Resolved recommendations
table pertaining toadministration of IV tPA in
setting of patient selection fortreatment outside therecommended window of 4.5
hours from onset andrecommendation 3 in Wakeup/Unclear Onset Timesection of Intravenous
Fibrinolysis recommendations
table also pertaining toadministration of IV tPA but
in the setting of “wake-up
stroke” (unclear time onset ofstroke).
Agree
The ICSI work group notesthat local practice should
account for the presence ofAcute Stroke-Ready Hospitals
in the state of Minnesota.
Patients should be rapidlytransported to the nearest
Acute Stroke-Ready Hospital,
which may include hospital
bypass. It is reasonable toconsider transporting patientswith suspected large vessel
occlusion stroke directly tocomprehensive stroke centers
if they are a similar distance toother Acute Stroke-Ready
Hospitals.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

39Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

2. Regional systems of stroke care should
be developed. These should consist of thefollowing:a. Healthcare facilities that provide
initial emergency !care, including
administration of intravenous
rtPA, such as primary stroke
centers, comprehensive stroke
centers, and other facilities, andb. Centers capable of performing
endovascular stroke treatment
with comprehensive
periprocedural care, including
comprehensive stroke centersand other healthcare facilities, towhich rapid transport can bearranged when appropriate(Class I; Level of Evidence A).
(Revised from the 2013 guideline)
3. It may be useful for primary stroke
centers and other health care facilities
that provide initial emergency care,including administration of intravenous
rtPA, to develop the capability of
performing emergency noninvasive
intracranial vascular imaging to mostappropriately select patients for transfer
for endovascular intervention and to
reduce the time to endovasculartreatment (Class IIb; Level of Evidence
C). (Revised from the 2013 guideline)
4. Endovascular therapy requires thepatient to be at an experienced stroke
center with rapid access to cerebral
angiography and qualified
neurointerventionalists. Systems should
be designed, executed, and monitored toemphasize expeditious assessment andtreatment. Outcomes for all patientsshould be tracked. Facilities areencouraged to define criteria that can beused to credential individuals who can
perform safe and timely intra-arterial
revascularization procedures (Class I;
Level of Evidence E). (Revised from the2013 guideline)

AHA/ASA ClassClass I:
Benefit>>>Risk

ICSI Work Group
Consensus

New Literature
Support

Qualification Statement/
Comment

Agree

Procedure/Treatment
SHOULD be performed/
administered.

Class IIb: Benefit ≥
Risk

Agree

Procedure/Treatment
MAY BECONSIDERED.

Class I:
Benefit>>>Risk

Agree

Procedure/Treatment
SHOULD be performed/
administered.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

40

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

AHA/ASA Class

New Literature
Support

Qualification Statement/
Comment

Anticoagulants
1. At present, the usefulness ofargatroban or other thrombin inhibitors
for treatment of patients with acuteischemic stroke is not well established(Class IIb; Level of Evidence B). These
agents should be used in the setting ofclinical trials. (New recommendation)

ICSI Work Group
Consensus

Class IIb: Benefit ≥
Risk

Agree

Wang, 2012

Agree

Wang, 2012

Paciaroni, 2015

Procedure/Treatment
MAY BECONSIDERED.

2. The usefulness of urgent
anticoagulation in patients with severe
stenosis of an internal carotid artery
ipsilateral to an ischemic stroke is notwell established (Class IIb; Level of
Evidence B). (New recommendation)

Class IIb: Benefit ≥Risk

4. Urgent anticoagulation for the
management of non- cerebrovascularconditions is not recommended forpatients with moderate-to-severe strokes
because of an increased risk of serious
intracranial hemorrhagic complications(Class III; Level of Evidence A).
(Unchanged from the previous guideline)

Procedure/Treatment
MAY BECONSIDERED.

3. Urgent anticoagulation, with the goalof preventing early recurrent stroke,halting neurological worsening, or
improving outcomes after acute ischemic
stroke, is not recommended for treatmentof patients with acute ischemic stroke(Class III; Level of Evidence A).
(Unchanged from the previous guideline)

Class III: Harm or No
Benefit

AgreeClass III: Harm or No
BenefitAgree

5. Initiation of anticoagulant therapy
within 24 hours of treatment withintravenous rtPA is not recommended(Class III; Level of Evidence B).
(Unchanged from the previous guideline)

Class III: Harm or No
BenefitAgree

1. Oral administration of aspirin (initial
dose is 325 mg) within 24 to 48 hours
after stroke onset is recommended fortreatment of most patients (Class I; Levelof Evidence A). (Unchanged from theprevious guideline)

Class I:
Benefit>>>Risk

Agree with qualification

Antiplatelet Agents

Procedure/Treatment
SHOULD be
performed/administered.

Rothwell, 2016

Earliest safe administration of
aspirin is important forsecondary stroke prevention.
(Rothwell, 2016) Detailed
discussion of secondary
prevention is beyond thepurview of this guideline.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

41

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

2. The usefulness of clopidogrel for thetreatment of acute ischemic stroke is notwell established (Class IIb; Level of
Evidence C). Further research testing theusefulness of the emergency
administration of clopidogrel in thetreatment of patients with acute stroke isrequired. (Revised from the previous
guideline)

AHA/ASA ClassClass IIb: Benefit ≥Risk

ICSI Work Group
Consensus

New Literature
Support

Qualification Statement/
Comment

Agree

Procedure/Treatment
MAY BECONSIDERED.

3. The efficacy of intravenous tirofibanand eptifibatide is not well established,
and these agents should be used only inthe setting of clinical trials (Class IIb;
Level of Evidence C). (Newrecommendation)

Class IIb: Benefit ≥Risk

5. The administration of otherintravenous antiplatelet agents that
inhibit the glycoprotein IIb/IIIa receptor
is not recommended (Class III; Level of
Evidence B). (Revised from the previous
guideline) Further research testing theusefulness of emergency administrationof these medications as a treatment
option in patients with acute ischemic
stroke is required.

Agree

Procedure/Treatment
MAY BECONSIDERED.

4. Aspirin is not recommended as a
substitute for other acute interventions
for treatment of stroke, including
intravenous rtPA (Class III; Level of
Evidence B). (Unchanged from the previous
guideline)

Class III: Harm or No
Benefit

AgreeClass III: Harm or No
BenefitAgree

6. The administration of aspirin (or otherantiplatelet agents) as an adjunctive
therapy within 24 hours of intravenous
fibrinolysis is not recommended (Class
III; Level of Evidence C). (Revised fromthe previous guideline)

Class III: Harm or No
BenefitAgree

1. The use of comprehensive specialized
stroke care (stroke units) thatincorporates rehabilitation isrecommended (Class I; Level of EvidenceA). (Unchanged from the previous
guideline)

Class I:
Benefit>>>Risk

Admission to the Hospital and General Acute Treatment (After Hospitalization)
Agree

Procedure/Treatment
SHOULD be performed/
administered.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

42Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

AHA/ASA Class

2. Patients with suspected pneumonia or
UTIs should be treated with appropriate
antibiotics (Class I; Level of Evidence A).
(Revised from the previous guideline)

Class I:
Benefit>>>Risk

3. Subcutaneous administration of
anticoagulants is recommended fortreatment of immobilized patients toprevent DVT (Class I; Level of EvidenceA). (Unchanged from the previous
guideline)

Class I:
Benefit>>>Risk

Procedure/Treatment
SHOULD be
performed/administered.

New Literature
Support

Qualification Statement/
Comment

Agree

Agree

Procedure/Treatment
SHOULD be
performed/administered.

4. The use of standardized stroke careorder sets is recommended to improvegeneral management (Class I; Level of
Evidence B). (Unchanged from the previous
guideline)

Class I:
Benefit>>>Risk

5. Assessment of swallowing before thepatient begins eating, drinking, or
receiving oral medications is
recommended (Class I; Level of EvidenceB). (Unchanged from the previous
guideline)

Class I:
Benefit>>>Risk

6. Patients who cannot take solid foodand liquids orally should receive NG,
nasoduodenal, or PEG tube feedings tomaintain hydration and nutrition while
undergoing efforts to restore swallowing(Class I; Level of Evidence B). (Revised
from the previous guideline)

ICSI Work Group
Consensus

Procedure/Treatment
SHOULD be
performed/administered.

Agree

Agree

Procedure/Treatment
SHOULD be
performed/administered.
Class I:
Benefit>>>Risk
Procedure/Treatment
SHOULD be
performed/administered.

Agree with qualification
The consensus of the ICSI
work group is to add thefollowing: “provided artificial
nutrition and hydration are inaccordance with the patient’s
wishes and goals of care.”
Therefore the recommendation
would state the following:
Patients who cannot takesolid food and liquids orally
should receive NG,
nasoduodenal or PEG tube
feedings to maintainhydration and nutrition
while undergoing efforts torestore swallowing provided
artificial nutrition andhydration are in accordancewith the patient’s wishes andgoals of care.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

43Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

7. Early mobilization of less severely
affected patients and measures to prevent
subacute complications of stroke arerecommended (Class I; Level of Evidence
C). (Unchanged from the previous
guideline)

AHA/ASA ClassClass I:
Benefit>>>Risk
Procedure/Treatment
SHOULD be
performed/administered.

ICSI Work Group
Consensus

New Literature
Support

Qualification Statement/
Comment

Agree with qualification

AVERT, 2015

AVERT 2015 study “Efficacy
and safety of very early
mobilization within 24 hoursof stroke onset (AVERT): a
randomized controlled trial”
found that very early
mobilization may not be
associated with favorable
outcomes at 3 months(AVERT, 2015).
Further research is needed on
this topic to determine theefficacy and safety of early
mobilization.

8. Treatment of concomitant medical
diseases is recommended (Class I; Levelof Evidence C). (Unchanged from theprevious guideline)

Class I:
Benefit>>>Risk

9. Early institution of interventions toprevent recurrent stroke is recommended(Class I; Level of Evidence C). (Unchanged
from the previous guideline)

Class I:
Benefit>>>Risk

10. The use of aspirin is reasonable fortreatment of patients who cannot receive
anticoagulants for DVT prophylaxis(Class IIa; Level of Evidence A). (Revised
from the previous guideline)
11. In selecting between NG and PEG
tube routes of feeding in patients who
cannot take solid food or liquids orally, it
is reasonable to prefer NG tube feeding
until 2 to 3 weeks after stroke onset (Class
IIa; Level of Evidence B). (Revised fromthe previous guideline)
12. The use of intermittent external
compression devices is reasonable fortreatment of patients who cannot receive
anticoagulants (Class IIa; Level of
Evidence B). (Revised from the previous
guideline)

Return to Table of Contents
Institute for Clinical Systems Improvement

Procedure/Treatment
SHOULD be
performed/administered.

Procedure/Treatment
SHOULD be
performed/administered.
Class IIa:
Benefit>>Risk

IT IS REASONABLE
to perform
procedure/administer
treatment.
Class IIa:
Benefit>>Risk

Agree

Agree

Agree

Agree

IT IS REASONABLE
to perform
procedure/administer
treatment.
Class IIa:
Benefit>>Risk

Agree

IT IS REASONABLE
to perform
procedure/administer
treatment.

www.icsi.org
44

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

AHA/ASA ClassICSI Work Group
Consensus
Qualification Statement/
Comment

13. Routine use of nutritional
supplements has not been shown to bebeneficial (Class III; Level of Evidence B).
(Revised from the previous guideline)

Class III: No Benefit

Agree

14. Routine use of prophylactic
antibiotics has not been shown to bebeneficial (Class III; Level of Evidence B).
(Revised from the previous guideline)

Class III: No Benefit

Agree

15. Routine placement of indwelling
bladder catheters is not recommended
because of the associated risk of catheterassociated UTIs (Class III; Level of
Evidence C). (Unchanged from the previous
guideline)

Class III: Harm or No
BenefitAgree

1. Patients with major infarctions are athigh risk for complicating brain edema
and increased ICP. Measures to lessen
the risk of edema and close monitoring of
the patient for signs of neurologicalworsening during the first days after
stroke are recommended (Class I; Levelof Evidence A). Early transfer of patientsat risk for malignant brain edema to an
institution with neurosurgical expertiseshould be considered. (Revised from theprevious guideline)

Class I:
Benefit>>>Risk

Treatment of Acute Neurological Complications

2. Decompressive surgical evacuation ofa space-occupying cerebellar infarction iseffective in preventing and treating
herniation and brain stem compression(Class I; Level of Evidence B). (Revised
from the previous guideline)

New Literature
Support

Agree

Procedure/Treatment
SHOULD be
performed/administered.

Class I:
Benefit>>>Risk

Agree

Procedure/Treatment
SHOULD be
performed/administered.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

45Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

AHA/ASA Class

3. Decompressive surgery for malignant
edema of the cerebral hemisphere iseffective and potentially lifesaving (ClassI; Level of Evidence B). Advanced patientage and patient/family valuations ofachievable outcome states may affectdecisions regarding surgery. (Revised
from the previous guideline)

Class I:
Benefit>>>Risk

4. Recurrent seizures after stroke shouldbe treated in a manner similar to otheracute neurological conditions, andantiepileptic agents should be selected by
specific patient characteristics (Class I;
Level of Evidence B). (Unchanged from theprevious guideline)

Class I:
Benefit>>>Risk

Procedure/Treatment
SHOULD be
performed/administered.

Class I:
Benefit>>>Risk

6. Although aggressive medical measures
have been recommended for treatment ofdeteriorating patients with malignant
brain edema after large cerebral
infarction, the usefulness of thesemeasures is not well established (Class
IIb; Level of Evidence C). (Revised fromthe previous guideline)

Class IIb: Benefit ≥Risk

Institute for Clinical Systems Improvement

New Literature
Support

Qualification Statement/
Comment
Agree with qualification

Streib, 2016

Decompressive surgery formalignant cerebral infarction
leads to improved mortality
and morbidity when
performed within 48 hours ofstroke onset. However, in spiteof improved outcome,survivors often havesignificant disability
secondary to their underlying
stroke. It is essential todetermine whether the
expected range of functional
outcomes post-decompressive
craniectomy is consistent withpatient and family goals ofcare. Clinical trials have also
specifically studied the benefitof decompressive craniectomy
for patients > 60 years old. In
this patient population,
outcomes were still improved
with decompressive
craniectomy, though
functional outcomes were
worse in comparison to their
younger counterparts (Streib,2016).
Agree

Procedure/Treatment
SHOULD be
performed/administered.

5. Placement of a ventricular drain is
useful in patients with acutehydrocephalus secondary to ischemic
stroke (Class I; Level of Evidence C).
(Revised from the previous guideline)

Return to Table of Contents

ICSI Work Group
Consensus

Procedure/Treatment
SHOULD be
performed/administered.

Agree

Agree

Procedure/Treatment
MAY BECONSIDERED.

www.icsi.org
46

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Recommendations
AHA/ASA Recommendation

7. Because of lack of evidence of efficacy
and the potential to increase the risk ofinfectious complications, corticosteroids(in conventional or large doses) are notrecommended for treatment of cerebral
edema and increased ICP complicating
ischemic stroke (Class III; Level of
Evidence A). (Unchanged from the previous
guideline)
8. Prophylactic use of anticonvulsants is
not recommended (Class III; Level of
Evidence C). (Unchanged from the previous
guideline)

AHA/ASA ClassICSI Work Group
Consensus

New Literature
Support

Qualification Statement/
Comment

Class III: Harm or No
Benefit

AgreeClass III: Harm or No
Benefit

Agree

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement47

Quality Improvement Support:

Diagnosis and Initial Treatment of Ischemic Stroke

The Aims and Measures section is intended to provide protocol users with a menu
of measures for multiple purposes that may include the following:• population health improvement measures,• quality improvement measures for delivery systems,• measures from regulatory organizations such as Joint Commission,• measures that are currently required for public reporting,• measures that are part of Center for Medicare Services Physician Quality
Reporting initiative, and• other measures from local and national organizations aimed at measuring
population health and improvement of care delivery.
This section provides resources, strategies and measurement for use in closing
the gap between current clinical practice and the recommendations set forth in theguideline.
The subdivisions of this section are:
• Aims and Measures

Copyright © 2016 by Institute for Clinical Systems Improvement

48

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Aims and Measures
1. Increase the percentage of patient's age 18 years and over receiving appropriate thrombolytic andappropriate antithrombotic therapy for ischemic stroke (tPA and aspirin, other antiplatelet agents, or an
anticoagulant).
Measure for accomplishing this aim:a.

Percentage of eligible patients with ischemic stroke treated with tPA.

2. Increase the percentage of stroke patients age 18 years and over who receive appropriate medical
management within the initial 24-48 hours of diagnosis for prevention of complications such as:•

Aspiration•

Deep vein thrombosis•

Nutritional status decline

Measures for accomplishing this aim:a.

Percentage of ischemic stroke patients with paralysis or other reason for immobility who receive
appropriate prevention for venous thromboembolism (subcutaneous heparin or pneumatic compression device).

b. Percentage of ischemic stroke patients who are assessed with a swallow screening test before
receiving food, fluids or medications by mouth.
Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

49

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Aims and Measures

Measurement Specifications
Measurement #1a

Percentage of eligible patients with ischemic stroke treated with tPA.

Population Definition

Patients age 18 years and older initially presenting with acute symptoms of ischemic stroke who are eligible
for tPA.

Data of Interest# of patients treated with tPA# of patients eligible for tPA

Numerator/Denominator Definitions
Numerator:

Number of patients who were treated with tPA.

Denominator:

Number of patients eligible for tPA treatment.

Method/Source of Data Collection

Review EHR for patients meeting criteria under population definition and determine the number of patientstreated with tPA.

Time Frame Pertaining to Data Collection
Monthly.

Notes

This is a process measure, and improvement is noted as an increase in the rate.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

50Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Aims and Measures

Measurement #2a

Percentage of patients with ischemic stroke with paralysis or other reason for immobility receiving appropriate prevention for venous thromboembolism (subcutaneous heparin or pneumatic compression device).

Population Definition

Patients age 18 years and older initially presenting with acute symptoms of ischemic stroke with paralysis
or other reason for immobility.

Data of Interest# of patients who have appropriate prevention for VTE# of patients who present with acute symptoms of ischemic stroke and paralysis or other reason forimmobility

Numerator and Denominator Definitions
Numerator:		

Number of patients who have appropriate prevention for VTE such as subcutaneous heparinor pneumatic compression device.

Denominator:		

Number of patients presenting with acute symptoms of ischemic stroke and paralysis orother reason for immobility.

Method/Source of Data Collection

Review EHR for patients meeting criteria under population definition and determine the number of patients
who have appropriate prevention for VTE.

Time Frame Pertaining to Data Collection
Monthly.

Notes

This is a process measure, and improvement is noted as an increase in the rate.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

51

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Aims and Measures

Measurement #2b

Percentage of ischemic stroke patients who are assessed with a swallow screening test before receiving
food, fluids or medications by mouth.

Population Definition

Patients age 18 years and older initially presenting with acute symptoms of ischemic stroke.

Data of Interest# of patients who receive an early swallow evaluation# of patients who present with acute ischemic stroke

Numerator and Denominator Definitions
Numerator:		

Number of patients who were screened for dysphagia before taking any food, fluids or
medication (including aspirin) by mouth.

Denominator:

Number of all patients presenting with symptoms of acute ischemic stroke.

Method/Source of Data Collection

Review EHR for patients meeting criteria under Population Definition and determine the number of patients
who have an early swallow evaluation.

Time Frame Pertaining to Data Collection
Monthly.

Notes

This is a process measure, and improvement is noted as an increase in the rate.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

52Supporting Evidence:

Diagnosis and Initial Treatment of Ischemic Stroke

The subdivisions of this section are:• References• Appendices

Copyright © 2016 by Institute for Clinical Systems Improvement

53Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

References

Links are provided for those new references added tothis edition (author name is highlighted in blue).

Albers GW, Goyal M, Jahan R, et al. Relationships between imaging assessments and outcomes insolitaire with the intention for thrombectomy as primary endovascular treatment for acute ischemic
stroke. Stroke 2015;46:2786-94.
AVERT Trial Collaboration group, Bernhardt J, Langhorne P, et al. Efficacy and safety of very early
mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet 2015;386:46-55.
Baldereschi M, Piccardi B, Di Carlo A, et al. Relevance of prehospital stroke code activation for acutetreatment measures in stroke care: a review. Cerebrovasc Dis 2012;34:182-90.
Bath PM, Krishnan K. Interventions for deliberately altering blood pressure in acute stroke. Cochrane
Database Syst Rev 2014;(10):CD000039.
Bennett MH, Weibel S, Wasiak J, et al. Hyperbaric oxygen therapy for acute ischaemic stroke. Cochrane
Database Syst Rev 2014;(11):CD004954.
Berge E, Cohen G, Lindley RI, et al. Effects of blood pressure and blood pressure-lowering treatment
during the first 24 hours among patients in the third international stroke trial of thrombolytic treatment
for acute ischemic stroke. Stroke 2015;46:3362-69.
Borst J, Berkhemer OA, Roos YB, et al. Value of computed tomographic perfusion-based patient selection for intra-arterial acute ischemic stroke treatment. Stroke 2015;46:3375-82.
Brandler ES, Sharma M, Sinert RH, Levine SR. Prehospital stroke scales in urban environments: asystematic review. Neurology 2014;82:2241-49.
Burton KR, Dhanoa D, Aviv RI, et al. Perfusion CT for selecting patients with acute ischemic stroke for
intravenous thrombolytic therapy. Radiology 2015;274:103-14.
Centers for Disease Control and Prevention. Stroke fact sheet. Available at: http://www.cdc.gov/dhdsp/
data_statistics/fact_sheets/docs/fs_stroke.pdf. 2016.
Chung HJ, Lee BH, Hwang YJ, et al. Delayed-phase CT angiography is superior to arterial-phase CT
angiography at localizing occlusion sites in acute stroke patients eligible for intra-arterial reperfusion
therapy. J Clin Neurosci 2014;21:596-600.
Demaerschalk BM, Bobrow BJ, Raman R, et al. CT interpretation in a telestroke network: agreement
among a spoke radiologist, hub vascular neurologist, and hub neuroradiologist. Stroke 2012a;43:309597.
Demaerschalk BM, Raman R, Ernstrom K, Meyer BC. Efficacy of telemedicine for stroke: pooled
analysis of the stroke team remote evaluation using a digital observation camera (STRokE DOC) andSTRokE dOC Arizona telestroke trials. Telemed J E Health 2012b;18:230-37.
Ekundayo OJ, Saver JL, Fonarow GC, et al. Patterns of emergency medical services use and its
association with timely stroke treatment: findings from get with the guidelines-stroke. Circ Cardiovasc
Qual Outcomes 2013;6:262-69.
Galinovic I, Puig J, Neeb L, et al. Visual and region of interest-based inter-rater agreement in theassessment of the diffusion-weighted imaging- fluid-attenuated inversion recovery mismatch. Stroke
2014;45:1170-72.
Goyal M, Menon BK, van Zwam WH, et al. Endovascular thrombectomy after large-vessel ischaemic
stroke: a meta-analysis of individual patient data from five randomised trials. Lancet 2016;387:1723-31.
He J, Zhang Y, Xu T, et al. Effects of immediate blood pressure reduction on death and major disability
in patients with acute ischemic stroke: the CATIS randomized clinical trial. JAMA 2014;311:479-89.

Return to Table of Contents
Institute for Clinical Systems Improvement

www.icsi.org
54

References

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Kidwell CS, Wintermark M, De Silva DA, et al. Multiparametric MRI and CT models of infarct core andfavorable penumbral imaging patterns in acute ischemic stroke. Stroke 2013;44:73-79.
Kochanek KD, Murphy SL, Xu J, Arias E. Mortality in the United States, 2013. NCHS Data Brief
2014;(178):1-8.
Lee M, Ovbiagele B, Hong KS, et al. Effect of blood pressure lowering in early ischemic stroke: metaanalysis. Stroke 2015;46:1883-89.
Lemmens R, Hamilton SA, Liebeskind DS, et al. Effect of endovascular reperfusion in relation to siteof arterial occlusion. Neurology 2016;86:762-70.
Lin L, Bivard A, Levi CR, Parsons MW. Comparison of computed tomographic and magnetic resonance perfusion measurements in acute ischemic stroke: back-to-back quantitative analysis. Stroke
2014;45:1727-32.
Malekzadeh J, Shafaee H, Behnam H, Mirhaghi A. The effect of Cincinnati prehospital stroke scaleon telephone triage of stroke patients: evidence-based practice in emergency medical services. Int J
Evid Based Healthc 2015;13:87-92.
Menon BK, d'Esterre CD, Qazi EM, et al. Multiphase CT angiography: a new tool for the imaging triageof patients with acute ischemic stroke. Radiology 2015;275:510-20.
Meyer BC, Raman R, Ernstrom K, et al. Assessment of long-term outcomes for the STRokE DOC
telemedicine trial. J Stroke Cerebrovasc Dis 2012;21:259-64.
Michel P, Ntaios G, Reichhart M, et al. Perfusion-CT guided intravenous thrombolysis in patients withunknown-onset stroke: a randomized, double-blind, placebo-controlled, pilot feasibility trial. Neuroradiology 2012;54:579-88.
Minnerup J, Ritter MA, Wersching H, et al. Continuous positive airway pressure ventilation for acuteischemic stroke: a randomized feasibility study. Stroke 2012;43:1137-39.
Mozzafarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics – 2015 update: a reportfrom the American heart association. Circulation 2015:e29-322.
Nagakane Y, Christensen S, Ogata T, et al. Moving beyond a single perfusion threshold to define
penumbra: a novel probabilistic mismatch definition. Stroke 2012;43:1548-55.
Oostema JA, Konen J, Chassee T, et al. Clinical predictors of accurate prehospital stroke recognition.
Stroke 2015;46:1513-17.
Oostema JA, Nasiri M, Chassee T, Reeves MJ. The quality of prehospital ischemic stroke care:compliance with guidelines and impact on in-hospital stroke response. J Stroke Cerebrovasc Dis
2014;23:2773-79.
Paciaroni M, Agnelli G, Falocci N, et al. Early recurrence and cerebral bleeding in patients with acuteischemic stroke and atrial fibrillation: effect of anticoagulation and its timing: the RAF study. Stroke
2015;46:2175-82.
Panezai S, Gezmu T, Kirmani J, et al. Compliance with joint commission measures in state-designatedstroke centers. J Hosp Med 2014;9:88-93.
Power M, Tyrrell PJ, Rudd AG, et al. Did a quality improvement collaborative make stroke care better?
A cluster randomized trial. Implement Sci 2014;9:40.
Rosso C, Pires C, Corvol JC, et al. Hyperglycaemia, insulin therapy and critical penumbral regions forprognosis in acute stroke: further insights from the INSULINFARCT trial. PLoS One 2015;10:e0120230.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement55

References

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Rothwell PM, Algra A, Chen Z, et al. Effects of aspirin on risk and severity of early recurrent stroke after
transient ischaemic attack and ischaemic stroke: time-course analysis of randomised trials. Lancet
2016;388:365-75.
Rudd M, Buck D, Ford GA, Price CI. A systematic review of stroke recognition instruments in hospitaland prehospital settings. Emerg Med J 2015.
Sanelli PC, Sykes JB, Ford AL, et al. Imaging and treatment of patients with acute stroke: an evidencebased review. AJNR Am J Neuroradiol 2014;35:1045-51.
Sarraj A, Sangha N, Hussain MS, et al. Endovascular therapy for acute ischemic stroke with occlusionof the middle cerebral artery M2 segment. JAMA Neurol 2016;73:1291-96.
Schönenberger S, Uhlmann L, Hacke W, et al. Effect of conscious sedation vs general anesthesia
on early neurological improvement among patients with ischemic stroke undergoing endovascularthrombectomy: a randomized clinical trial. JAMA 2016;316:1986-96.
Schröder J, Cheng B, Ebinger M, et al. Validity of acute stroke lesion volume estimation by diffusionweighted imaging-Alberta stroke program early computed tomographic score depends on lesion locationin 496 patients with middle cerebral artery stroke. Stroke 2014;45:3583-88.
Spokoyny I, Raman R, Ernstrom K, et al. Pooled assessment of computed tomography interpretation by
vascular neurologists in the STRokE DOC telestroke network. J Stroke Cerebrovasc Dis 2014;23:511-15.
Streib CD, Hartman LM, Molyneaux BJ. Early decompressive craniectomy for malignant cerebral
infarction: meta-analysis and clinical decision algorithm. Neurol Clin Pract 2016;6:433-43.
Switzer JA, Singh R, Mathiassen L, et al. Telestroke: variations in intravenous thrombolysis by spoke
hospitals. J Stroke Cerebrovasc Dis 2015;24:739-44.
van den Wijngaard IR, Boiten J, Holswilder G, et al. Impact of collateral status evaluated by dynamic
computed tomographic angiography on clinical outcome in patients with ischemic stroke. Stroke
2015;46:3398-404.
Wang Q, Chen C, Chen XY, et al. Low-molecular-weight heparin and early neurologic deterioration inacute stroke caused by large artery occlusive disease. Arch Neurol 2012;69:1454-60.
Zhao R, Liu FD, Wang S, et al. Blood pressure reduction in the acute phase of an ischemic stroke
does not improve short- or long-term dependency or mortality: a meta-analysis of current literature.
Medicine (Baltimore) 2015;94:e896.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

56

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Appendix A – Literature Search Terms by Topic
Public Stroke Education and Prehospital Stroke Management
Educational stroke programs for physicians, hospital personnel and EMS personnel, 911 activation for stroke
patients, prehospital stroke assessment tools, Los Angeles Prehospital Stroke Screen, Cincinnati Prehospital Stroke Scale, stroke protocol for EMS personnel, EMS transportation for stroke patients, prehospital
notification for stroke patients.

Designation of Stroke Centers and Stroke Care Quality Improvement Process
Primary stroke center, acute stroke-ready hospital, comprehensive stroke center, certification of stroke centers,
multidisciplinary quality improvement committee for stroke, data repository for stroke care, teleradiology
for acute stroke, telestroke network, telestroke and tPA, telestroke and community hospitals.

Emergency Evaluation and Diagnosis of Acute Ischemic Stroke
ER protocol for stroke, fibrinolytic treatment for stroke in the ER, acute stroke team in the ER, stroke rating
scale, NIH Stroke Scale/Score, laboratory tests for stroke patients, laboratory tests and rtPA administration,
blood glucose and rtPA, baseline electrocardiogram assessment in acute ischemic stroke patients, baseline
troponin assessment in acute ischemic stroke patients, chest radiographs in acute ischemic stroke patients.

Early Diagnosis: Brain and Vascular Imaging: Recommendations for Patients With Acute
Cerebral Ischemic Symptoms That Have Not Yet Resolved
Brain imaging for acute ischemic stroke, non-contrast-enhanced computed tomography in acute ischemic
stroke patients, NECT and rtPA administration, MRI and rTPA administration, exclusion of intracranial
hemorrhage in stroke patients, intravenous fibrinolytic therapy for early ischemic changes on CT, noninvasive intracranial vascular study and imaging for acute stroke patients, non-invasive intracranial study
and intra-arterial fibrinolysis, non-invasive intracranial study and mechanical thrombectomy, What is thetime frame for the brain imaging study interpretation in intravenous fibrinolysis candidates?, perfusion CT,
perfusion MRI, wake-up stroke, penumbra imaging, frank hypodensity on NECT.

General Supportive Care and Treatment of Acute Complications
What cardiac monitoring should be done for ischemic stroke patients?, How should blood pressure becontrolled prior to initiating fibrinolytic therapy?, What should blood pressure be after giving fibrinolytic
therapy?, airway support and ventilator assistance for ischemic stroke, When should you give supplemental
oxygen to an ischemic stroke patient?, hyperthermia and ischemic stroke, blood pressure control and intraarterial fibrinolysis, blood pressure control for ischemic stroke patients who do not receive fibrinolysis,
management of hypovolemia in acute ischemic stroke, management of hypoglycemia in acute ischemic
stroke, When to start antihypertensive therapy after stroke in patients without preexisting hypertension
and in patients with preexisting hypertension?, blood pressure medications to use for acute ischemic stroke
patients, hyperglycemia and acute ischemic stroke, management of arterial hypertension in patients withacute ischemic stroke, Use of supplemental oxygen in non-hypoxic patients with acute ischemic stroke.

Admission to the Hospital and General Acute Treatment (After Hospitalization)
Comprehensive stroke care with rehabilitation, suspected pneumonia in patients with acute ischemic stroke,suspected urinary tract infection in patients with acute ischemic stroke, DVT prophylaxis in immobilized
patients with acute ischemic stroke, standardized stroke care order sets for management of acute ischemic
stroke, assessment of swallowing for stroke patients, feeding stroke patients unable to take food orally, early
mobilization in stroke patients, treatment on concomitant medical diseases for patients with acute ischemic
Return to Table of Contents
Institute for Clinical Systems Improvement

www.icsi.org
57

Appendix A – Literature Search Terms by Topic

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

stroke, prevention of recurrent stroke in the acute ischemic stroke patient, aspirin for DVT prophylaxis forstroke patients unable to receive anticoagulants, nasogastric (NG) versus percutaneous endoscopic gastrostomy (PEG) tube feeding after stroke onset, intermittent external compression device for DVT prophylaxis
in stroke patients unable to take anticoagulants, nutritional supplements in acute stroke patients, prophylactic
antibiotics in acute stroke patients, indwelling bladder catheter in acute stroke patients.

Treatment of Acute Neurological Complications
ICP management, management of increased intercranial pressure in stroke, decompressive surgical evacuation of a space-occupying cerebral infarction, decompressive surgery for malignant edema of the cerebral
hemisphere, treatment of recurrent seizures after stroke, treatment of acute hydrocephalus secondary toischemic stroke, ventricular drain for acute hydrocephalus secondary to ischemic stroke, use of corticosteroids to treat cerebral edema and increased intracranial pressure from ischemic stroke, prophylactic use of
anticonvulsants for stroke patient.
Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

58Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Appendix B – ICSI Shared Decision-Making Model

The Collaborative Conversation™ Shared Decision-Making
and the Translation of Evidence into Practice

A consistent finding from clinical and health services research is the failure to translate research into practice. The translation of evidence into practice can be advanced through the use of shared decision-making
since shared decision-making results in evidence being incorporated into patient and clinician consultations.
Shared decision-making (SDM) is a process in which patient and clinicians collaborate to clarify all acceptable options, ensure that the patient is well-informed and chose a course of care consistent with patient values
and preferences and the best available medical evidence. (Minnesota Shared Decision-Making Collaborative[MSDMC], 2011).
Evidence-based guidelines may recommend the use of shared decision-making for decisions in instanceswhere the evidence is equivocal, when patient action or inaction (such as medication adherence or lifestylechanges) can impact the potential outcome, or when the evidence does not indicate a single best recommendation.
SDM is a patient-centered approach that involves a conversation between the patient and the clinician. It is
ideal to involve caregivers and family members in these conversations, as well. Family members and caregivers can participate in discussions, ask questions, hear content the patient may miss and provide invaluable support in decision follow-through. Although only patients and clinicians are specifically mentioned
throughout this document for brevity purposes, this does not diminish the importance of caregivers andfamilies in patient-centered care.
Both the patient and the clinician bring expertise to the shared decision-making conversation. Clinicians'
expertise includes disease etiology, prognosis, options for treatment including the burden and benefit to thepatient, and outcome probabilities. Patients' expertise lies in their knowledge of their risk tolerance, body,
priorities, family and financial issues, as well as their daily experience with the condition (adapted from
Making Shared Decision-Making a Reality. No decision about me, without me. Coulter, A., Collins, A.,
The King's Fund 2011).
Treatment options vary in their burden on a patient. SDM offers an opportunity to help the patient select atreatment to which they can adhere. When conversations discussing options occurs, patients and clinicians
are actively engaged while considering the attributes and issues of the available options. This empathic
approach results in the clinician and patient co-creating a decision and a plan of care (adapted from Montori,V., the Mayo Clinic KER UNIT, April 2015). Decision aids can be supportive of this conversation when they
communicate the best available evidence to inform the patient and clinician discussion.
Without a conversation, clinicians may make assumptions about what the patient prefers. This creates thepotential for discrepancies between what clinicians assume and what patients want, resulting in a "preference misdiagnosis" (adapted from Health Policy Publishing, LLC, May 2013).
Difficulty in initiating a conversation is cited by patients and clinicians as one of the barriers to shareddecision-making. To address this impediment, ICSI worked with patients, practicing clinicians, and otherstakeholders to develop the Collaborative Conversation™ model for use across the care continuum.
Return to Table of Contents
Institute for Clinical Systems Improvement

www.icsi.org
59

Appendix B – ICSI Shared Decision-Making Model

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Collaborative Conversation™
A collaborative approach towards decision-making is a fundamental tenet of Shared Decision-Making (SDM).
The Collaborative Conversation™ is an inter professional approach that nurtures relationships; enhances
patients' knowledge, skills and confidence as vital participants in their health; and encourages them tomanage their health care. Within a Collaborative Conversation™, the perspective is that the patient, rather
than the clinician, knows which course of action is most consistent with the patient's values and preferences.
Use of Collaborative Conversation™ elements and tools is even more necessary to support patient, careclinician and team relationships when patients and families are dealing with high stakes or highly charged
issues. A diagnosis of a life-limiting illness is one example of such a circumstance.
The overall objective for the Collaborative Conversation™ approach is to create an environment in which
the patient, family and care team work collaboratively to reach and carry out a decision that is consistent
with the patient's values and preferences, along with the best available evidence. A rote script, completed
form or checklist does not constitute this approach. Rather it is a set of skills employed appropriately forthe specific situation. These skills need to be used artfully to address all aspects of the person involved in
making a decision: cognitive, affective, social and spiritual.
Key communication skills help build the collaborative conversation approach. These skills include (Adaptedfrom O'Connor, Jacobsen Decisional Conflict: Supporting People Experiencing Uncertainty about Options
Affecting their Health [2007], and Bunn H, O'Connor AM, Jacobsen MJ Analyzing decision support andrelated communication [1998, 2003])
1. Listening skills
Encourage patient to talk by providing prompts to continue such as go on, and then? and uh huhor by repeating the last thing a person said, It's confusing.
Paraphrase content of messages shared by patient to promote exploration, clarify content andto communicate that the person's unique perspective has been heard. The clinician should use theirown words rather than just parroting what they heard.
Reflection of feelings usually can be done effectively once trust has been established. Until the clinician feels that trust has been established, short reflections at the same level of intensity expressed by
the patient without omitting any of the message's meaning are appropriate. Reflection in this mannercommunicates that the clinician understands the patient's feelings and may work as a catalyst for
further problem solving. For example, the clinician identifies what the person is feeling and responds
back in his or her own words like this: "So, you're unsure which choice is the best for you."
Summarize the person's key comments and reflect them back to the patient. The clinician should
condense several key comments made by the patient and provide a summary of the situation. This
assists the patient in gaining a broader understanding of the situation rather than getting mireddown in the details. The most effective times to do this are midway through and at the end of theconversation. An example of this is "You and your family have read the information together,
discussed the pros and cons, but are having a hard time making a decision because of the risks."
Perception checks ensure that the clinician accurately understands a patient or family member
perspective, and may be used as a summary or reflection. They are used to verify that the clinician
is interpreting the message correctly. The clinician can say, "So you are saying that you're notready to make a decision at this time. Am I understanding you correctly?"
Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement60Appendix B – ICSI Shared Decision-Making Model

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

2. Questioning Skills
Open and closed questions are both used, with the emphasis on open questions. Open questions ask
for clarification or elaboration and cannot have a yes or no answer. An example would be, "Whatelse would influence you to choose this?" Closed questions are appropriate if specific informationis required, such as "Does your daughter support your decision?"
Other skills such as summarizing, paraphrasing, and reflection of feeling can be used in the questioning process so that the patient doesn't feel pressured by questions.
Verbal tracking, referring back to a topic the patient mentioned earlier, is an important foundational
skill (Ivey & Bradford-Ivey). An example of this is the clinician saying, "You mentioned earlier…"
3. Information-Giving Skills
Providing information and providing feedback are two methods of information giving. The
distinction between providing information and giving advice is important. Information giving
allows a clinician to supplement his or her knowledge and helps to keep the conversation patient
centered. Giving advice, on the other hand, takes the attention away from the patient's unique goals
and values, and places it on those of the clinician.
Providing information can be sharing facts or responding to questions. An example is "If we lookat the evidence, the risk is…" Providing feedback gives the patient the clinician's view of thepatient's reaction. For instance, the clinician can say, "You seem to understand the facts and value
your daughter's advice."

When to Initiate a Collaborative Conversation™
Certain seminal events occur along the care continuum, creating especially opportune times for collaborative conversations. More than one of these opportunities may present at a time, and they will occur in no
specific order.

Table 1Return to Table of Contents
Institute for Clinical Systems Improvement

www.icsi.org
61

Appendix B – ICSI Shared Decision-Making Model

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Cues for the Care Team to Initiate a Collaborative Conversation™:•

Life goal changes: Patient's priorities change related to things the patient values such as activities,
relationships, possessions, goals and hopes, or things that contribute to the patient's emotional andspiritual well-being.

•

Diagnosis/prognosis changes: Additional diagnoses, improved or worsening prognosis.

•

Change or decline in health status: Improving or worsening symptoms, change in performancestatus or psychological distress.

•

Change or lack of support: Increase or decrease in caregiver support, change in caregiver, change
in caregiver status, change in financial standing, difference between patient and family wishes.

•

Disease progression: Change in physical or psychological status as a result of the disease progression.

•

Clinician/caregiver contact: Each contact between the clinician/ caregiver presents an opportunity
to reaffirm with the patient that the care plan and the care he or she is receiving are consistent withhis or her values.

Patient and Family Needs within a Collaborative Conversation™
•

Request for support and information: Decisional conflict is indicated by, among other things, thepatient verbalizing uncertainty or concern about undesired outcomes, expressing concern about
choice consistency with personal values, or exhibiting behavior such as wavering, delay, preoccupation, distress or tension. Support resources may include health care professionals, family,
friends, support groups, clergy and social workers. When patient expresses a need for information
regarding options and their potential outcomes, the patient should understand the key facts about
the options, risks and benefits, and have realistic expectations. The method and pace with which
this information is provided to the patient should be appropriate for the patient's capacity at thatmoment.

•Advance Care Planning: With the diagnosis of a life-limiting illness, conversations around advancecare planning open up. This is an opportune time to expand the scope of the conversation to othertypes of decisions that will need to be made as a consequence of the diagnosis of a life-limiting
illness.

•

Consideration of Values: The personal importance a patient assigns potential outcomes must be
respected. If the patient is unclear how to prioritize his or her preferences, value clarification canbe achieved through the use of decision aids, detailing the benefits and harms of potential outcomesin terms of how they will directly affect the patient, and through collaborative conversations withthe clinician.

•Trust: The patient must feel confident that his or her preferences will be communicated to andrespected by all caregivers.

•

Care Coordination: Should the patient require care coordination, this is an opportune time to discuss
the other types of care-related decisions that need to be made. These decisions will most likely need
to be revisited often. Further, the care delivery system must be capable of delivering coordinatedcare throughout the continuum of care.

•

Responsive Care System: The care system needs to support the components of patient- and familycentered care so the patient's values and preferences are incorporated into the care he or she receives
throughout the care continuum.

Return to Table of Contents
Institute for Clinical Systems Improvement

www.icsi.org
62

Appendix B – ICSI Shared Decision-Making Model

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

The Collaborative Conversation™ Map is the heart of this process. The Collaborative Conversation Map™
can be used as a stand-alone tool that is equally applicable to clinicians and patients, as shown in Table 2.
Clinicians use the map as a clinical workflow. It helps get the shared decision-making process initiated andprovides navigation for the process. Care teams can use the Collaborative Conversation™ to document teambest practices and to formalize a common lexicon. Organizations can build fields from the Collaborative
Conversation™ Map in electronic medical records to encourage process normalization. Patients use themap to prepare for decision-making, to help guide them through the process and to share critical information with their loved ones.

Table 2Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

63Appendix B – ICSI Shared Decision-Making Model

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Evaluating Shared Decision-Making
It has proven challenging to assess shared decision-making. Measuring shared decision-making remains
important for continued adoption of shared decision-making as a mechanism for translating evidence into
practice; promoting patient-centered care; and understanding the impact of shared decision-making on
patient experience, outcomes and revenues. Many assessments exist, but they are often proxy measures.
Two suggested methods for measuring shared decision-making are the CollaboRATE tool and the SURE
Test. These two tools measure different aspects of shared decision-making, as described below.
The CollaboRATE tool measures the level of shared decision-making in the clinical encounter from thepatient's perspective. It is a brief patient-reported measure of shared decision-making. The tools and guidance on their use can be found at http://www.collaboratescore.org/.
The SURE Test is a brief screening questionnaire the patient uses to access his or her readiness and capacity
to make a decision or to determine whether he or she is comfortable with the choice that was made. In otherwords, it provides information on how likely a patient may be experiencing decisional conflict. If the SURE
Test indicates decisional conflict may exist, the Decisional Conflict Scale should be completed in order toassess clinically significant decisional conflict.
Shared decision-making is a useful mechanism for translating evidence into practice. While research on
the impacts of shared decision-making continues to grow, there is mounting evidence that both patientsand clinicians benefit from SDM. Shared decision-making offers the opportunity to bring evidence and thepatient's values into the patient/clinician discussion of health choices.
Copyright © 2012, 2016 by Institute for Clinical Systems Improvement. All rights reserved.

8009 34th Avenue South, Suite 1200 • Bloomington, MN 55425 • Phone: 952-814-7060 • www.icsi.org© 2012 Institute for Clinical Systems Improvement. All rights reserved.
Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

64

Disclosure of Potential Conflicts of Interest:

Diagnosis and Initial Treatment of Ischemic Stroke

ICSI has long had a policy of transparency in declaring potential conflicting andcompeting interests of all individuals who participate in the development, revision
and approval of ICSI guidelines and protocols.
In 2010, the ICSI Conflict of Interest Review Committee was established by the
Board of Directors to review all disclosures and make recommendations to the board
when steps should be taken to mitigate potential conflicts of interest, including
recommendations regarding removal of work group members. This committee
has adopted the Institute of Medicine Conflict of Interest standards as outlined in
the report, Clinical Practice Guidelines We Can Trust (2011).
Where there are work group members with identified potential conflicts, these aredisclosed and discussed at the initial work group meeting. These members are
expected to recuse themselves from related discussions or authorship of related
recommendations, as directed by the Conflict of Interest committee or requestedby the work group.
The complete ICSI policy regarding Conflicts of Interest is available at
http://bit.ly/ICSICOI.
Funding Source

The Institute for Clinical Systems Improvement provided the funding for thisguideline revision. ICSI is a not-for-profit, quality improvement organization
based in Bloomington, Minnesota. ICSI's work is funded by the annual duesof the member medical groups and three sponsoring health plans in Minnesota.
Individuals on the work group are not paid by ICSI but are supported by their
medical group for this work.
The only exception to this, patient and public members of a work group, areprovided with a small stipend to cover meeting attendance.
ICSI facilitates and coordinates the guideline development and revision process.
ICSI, member medical groups and sponsoring health plans review and provide
feedback but do not have editorial control over the work group. All recommendations are based on the work group's independent evaluation of the evidence.
Return to Table of Contents

Copyright © 2016 by Institute for Clinical Systems Improvement

65Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Disclosure of Potential Conflicts of Interest

David Anderson, MD (Work Group Leader)
Professor, University of Minnesota Department of Neurology; University of Minnesota Physicians, Hennepin
County Medical Center
National, Regional, Local Committee Affiliations: DSMB Member; Editor: Continuum Audio; Editor:
Neurology Clinical Practices
Guideline-Related Activities: None
Research Grants: None
Financial/Non-Financial Conflicts of Interest: None
Ann Ferguson, MD (Work Group Member)Internal Medicine/Pediatrics; Fairview Health Services
National, Regional, Local Committee Affiliations: None
Guideline Related Activities: None
Research Grants: None
Financial/Non-Financial Conflicts of Interest: None
James Klaas, MD (Work Group Member)
Assistant Professor, Neurology, Mayo Clinic
National, Regional, Local Committee Affiliations: None
Guideline-Related Activities: None
Research Grants: None
Financial/Non-Financial Conflicts of Interest: None
Fadoua Kushner, PharmD (Work Group Member)
Clinical Staff Pharmacist, Pharmacy; Park Nicollet Health Services – Methodist Hospital
National, Regional, Local Committee Affiliations: None
Guideline-Related Activities: None
Research Grants: None
Financial/Non-Financial Conflicts of Interest: NoneDavid Larson, MD, FACEP (Work Group Member)
Emergency Medicine, Medical Director, Ridgeview Emergency Department; Ridgeview Medical Center
National, Regional, Local Committee Affiliations: Board Member of CALS Program – Comprehensive
Advanced Life Support
Guideline-Related Activities: None
Research Grants: None
Financial/Non-Financial Conflicts of Interest: None
Bjorn Peterson, MD (Work Group Member)
Emergency Medicine, Emergency Department Medical Director; Health Partners Medical Group andRegions Hospital
National, Regional, Local Committee Affiliations: None
Guideline-Related Activities: None
Research Grants: None
Financial/Non-Financial Conflicts of Interest: None
Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

66

Disclosure of Potential Conflicts of Interest

Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016

Tess Sierzant, MS, RN, ACNS-BC (Work Group Member)
Neuroscience Clinical Nurse Specialist, Neuroscience Nursing; HealthEast Care System
National, Regional, Local Committee Affiliations: Board Membership and President, Neuroscience Nursing
Foundation, Professional Advisory Board, Epilepsy Foundation
Guideline-Related Activities: None
Research Grants: None
Financial/Non-Financial Conflicts of Interest: None
Christopher Streib (Work Group Member)
Assistant Professor, University of Minnesota Department of Neurology; Vascular Neurology; Universityof Minnesota Physicians
National, Regional, Local Committee Affiliations: None
Guideline-Related Activities: None
Research Grants: None
Financial/Non-Financial Conflicts of Interest: None
Ruth Marie Thomson, DO (Work Group Member)
Vascular Neurologist, Neurology; Minneapolis Clinic of Neurology
National, Regional, Local Committee Affiliations: None
Guideline-Related Activities: None
Research Grants: None
Financial/Non-Financial Conflicts of Interest: None
Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement

67External Review and Acknowledgements:

Diagnosis and Initial Treatment of Ischemic Stroke

ICSI seeks review from members and the public during the revision process.

Member Review
All ICSI documents are available for member review at two points in the ICSI revision process.
The ICSI Response Report is sent to members at the beginning of a document revision. The
goal of this report is to solicit feedback about the guideline, including but not limited to thealgorithm, content, recommendations, and implementation. Members are also welcome toparticipate in the public comment period (see below).
The work group would like to thank the following organizations for participating in the Diagnosis and Initial Treatment of Ischemic Stroke pre-revision review:•

Hudson Physicians

Invited Reviews
For some guidelines, ICSI will invite experts in the community to comment on a guideline
draft prior to finalization. This is done during the public comment period.
No invited review was done for the Diagnosis and Initial Treatment of Ischemic Stroke guideline.

ICSI Patient Advisory Council (PAC)
The ICSI Patient Advisory Council responds to any guideline review requests put forth by ICSI
facilitators and work groups. The PAC members may be involved at the beginning, middle,
and/or end of the revision process. Patient advisors who serve on the council consistently share
their experiences and perspectives in either a comprehensive or partial review of a document.
The ICSI Patient Advisory Council did not review the Diagnosis and Initial Treatment ofIschemic Stroke guideline.
Return to Table of Contents

Copyright © 2016 by Institute for Clinical Systems Improvement

68Document History and Development:

Diagnosis and Initial Treatment of Ischemic Stroke
Original Work Group Members

Document Drafted
Jan – Jun 2000

Ansar Ahmed, MD
Neurology
HealthPartners Medical
Group
David Anderson, MD
Neurology
Hennepin County Medical
CenterDiane Davies, MD
BHCAG Representative
PfizerSpring Davis, RN, BSN
Health Education
HealthPartners Health Plan
Sandra Hanson, MD
Neurology, Work Group Leader
Park Nicollet Health Services

First Edition
Oct 2001
Second Edition
Nov 2002
Third Edition
Nov 2003
Fourth Edition
Feb 2005
Fifth Edition
Mar 2006
Sixth Edition
Begins March 2007
Seventh Edition
Jul 2008
Eighth Edition
Jul 2009
Ninth Edition
Jul 2010

Diane Jacobsen, MPH
Measurement Advisor
ICSI
James Lee, MD, MPH
Family PracticeRiverWay Clinics
Joseph McRaith, MD
Internal Medicine
Aspen Medical Group
Barbara Mullikin, MS
Facilitator
ICSI

Kathleen Neacy, MD
Emergency Medicine
HealthPartners Medical
Group
Manuel Ramirez-Lassepas, MD
Neurology
HealthPartners Medical
Group
Kathryn Schultz, PharmD
Pharmacy
Allina Medical Clinic
Eelco Wijdicks, MD
Neurology
Mayo Clinic

Tenth Edition
Aug 2012

Eleventh Edition
Begins Dec 2016

The next revision will be no later than December 2021.

Document History•

2012 implemented the GRADE methodology to identify and evaluate recommendations.

•

2016: Original content was discontinued.

Return to Table of Contents
Contact ICSI at:
8009 34th Avenue South, Suite 1200; Bloomington, MN 55425; (952) 814-7060; (952) 858-9675 (fax)
Online at http://www.icsi.org
Copyright © 2016 by Institute for Clinical Systems Improvement

69Diagnosis and Initial Treatment of Ischemic Stroke

Eleventh Edition/December 2016ICSI Document Development and Revision Process
Overview

Since 1993, the Institute for Clinical Systems Improvement (ICSI) has developed more than 60 evidence-based
health care documents that support best practices for the prevention, diagnosis, treatment or management of agiven symptom, disease or condition for patients.

Audience and Intended Use

The information contained in this ICSI health care guideline is intended primarily for health professionals andother expert audiences.
This ICSI health care guideline should not be construed as medical advice or medical opinion related to any
specific facts or circumstances. Patients and families are urged to consult a health care professional regarding theirown situation and any specific medical questions they may have. In addition, they should seek assistance froma health care professional in interpreting this ICSI health care guideline and applying it in their individual case.
This ICSI health care guideline is designed to assist clinicians by providing an analytical framework for theevaluation and treatment of patients, and is not intended either to replace a clinician's judgment or to establish a
protocol for all patients with a particular condition.

Document Development and Revision Process

The development process is based on a number of long-proven approaches and is continually being revised
based on changing community standards. The ICSI staff, in consultation with the work group and a medical
librarian, conduct a literature search to identify systematic reviews, randomized clinical trials, meta-analysis,other guidelines, regulatory statements and other pertinent literature. This literature is evaluated based on the
GRADE methodology by work group members. When needed, an outside methodologist is consulted.
The work group uses this information to develop or revise clinical flows and algorithms, write recommendations,and identify gaps in the literature. The work group gives consideration to the importance of many issues as they
develop the guideline. These considerations include the systems of care in our community and how resources
vary, the balance between benefits and harms of interventions, patient and community values, the autonomy ofclinicians and patients and more. All decisions made by the work group are done using a consensus process.

ICSI's medical group members and sponsors review each guideline as part of the revision process. They provide
comment on the scientific content, recommendations and implementation strategies. This feedback is used byand responded to by the work group as part of their revision work. Final review and approval of the guideline
is done by ICSI's Committee on Evidence-Based Practice. This committee is made up of practicing clinicians
and nurses, drawn from ICSI member medical groups.

Implementation Recommendations and Measures

These are provided to assist medical groups and others to implement the recommendations in the guidelines.
Where possible, implementation strategies are included that have been formally evaluated and tested. Measures
are included that may be used for quality improvement as well as for outcome reporting. When available, regulatory or publicly reported measures are included.

Document Revision Cycle

Scientific documents are revised as indicated by changes in clinical practice and literature. ICSI staff monitors
major peer-reviewed journals for any pertinent evidence that would affect a particular guideline and recommendation.

Return to Table of Contents

www.icsi.org
Institute for Clinical Systems Improvement70