[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Notices]
[Pages 3594-3596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-00763]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request on Noninvasive Testing for 
Coronary Artery Disease

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for Scientific Information Submissions.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review of ``Noninvasive 
Testing for Coronary Artery Disease'', which is currently being 
conducted by the AHRQ's Evidence-based Practice Centers (EPC) Programs. 
Access to published and unpublished pertinent scientific information 
will improve the quality of this review. AHRQ is conducting this 
systematic review pursuant to Section 902(a) of the Public Health 
Service Act, 42 U.S.C. 299a(a).

DATES: Submission Deadline on or before February 23, 2015.

ADDRESSES: Online submissions: http://effectivehealthcare.AHRQ.gov/index.cfm/submit-scientific-information-packets/. Please select the 
study for which you are submitting information from the list to upload 
your documents.
    Email submissions: <a href="/cdn-cgi/l/email-protection#02514b5251426772612f3e63226a7067643f" http: src.org">src.org</a>">SIPS@epc-src.org</a>.
    Print submissions:
    Mailing Address: Portland VA Research Foundation,Scientific 
Resource Center, ATTN: Scientific Information Packet Coordinator, PO 
Box 69539, Portland, OR 97239. Shipping Address (FedEx, UPS, etc.): 
Portland VA Research Foundation, Scientific Resource Center, ATTN: 
Scientific Information Packet Coordinator, 3710 SW U.S. Veterans 
Hospital Road, Mail Code: R&D 71, Portland, OR 97239.

FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262 
ext. 58653 or Email: <a href="/cdn-cgi/l/email-protection#e7b4aeb7b4a7829784cadb86c78f958281da" http: src.org">src.org</a>">SIPS@epc-src.org</a>.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Programs to complete a review of the evidence for ``Noninvasive Testing 
for Coronary Artery Disease''.
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on ``Noninvasive Testing for Coronary Artery Disease'', 
including those that describe adverse events. The entire research 
protocol, including the key questions, is also available online at: 
http://effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=2017.

[[Page 3595]]

    This notice is to notify the public that the EPC Program would find 
the following information on ``Noninvasive Testing for Coronary Artery 
Disease'' helpful:
    <bullet> A list of completed studies that your organization has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
    <bullet> For completed studies that do not have results on 
ClinicalTrials.gov, please provide a summary, including the following 
elements: Study number, study period, design, methodology, indication 
and diagnosis, proper use instructions, inclusion and exclusion 
criteria, primary and secondary outcomes, baseline characteristics, 
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
    <bullet> A list of ongoing studies that your organization has 
sponsored for this indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including a study number, the study period, 
design, methodology, indication and diagnosis, proper use instructions, 
inclusion and exclusion criteria, and primary and secondary outcomes.
    <bullet> Description of whether the above studies constitute all 
Phase II and above clinical trials sponsored by your organization for 
this indication and an index outlining the relevant information in each 
submitted file.
    Your contribution will be very beneficial to the EPC Program. The 
contents of all submissions will be made available to the public upon 
request. Materials submitted must be publicly available or can be made 
public. Materials that are considered confidential; marketing 
materials; study types not included in the review; or information on 
indications not included in the review cannot be used by the EPC 
Program. This is a voluntary request for information, and all costs for 
complying with this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC program Web 
site and available for public comment for a period of 4 weeks. If you 
would like to be notified when the draft is posted, please sign up for 
the email list at: http://effectivehealthcare.AHRQ.gov/index.cfm/join-the-email-list1/.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions. The entire research 
protocol, is available online at: http://effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=isplayproduct&productID=2017.

The Key Questions

    In stable, symptomatic patients with suspected coronary artery 
disease (CAD) who do not have previously diagnosed CAD and who have had 
a resting electrocardiogram (ECG):
    1. For patients considered to be at very low or low risk for CAD, 
what is the comparative effectiveness of anatomic tests (compared with 
each other, standard of care, or no testing):
    (a) For improving primary clinical health outcomes (e.g., quality 
of life, avoiding myocardial infarction)? In the absence of comparative 
studies linking testing with outcomes, do the tests predict future 
clinical events (predictive accuracy)?
    (b) What are the adverse effects, consequences, or harms of 
testing?
    (c) How do noninvasive tests differ in terms of clinical management 
based on test results, including referral for coronary angiography or 
additional noninvasive testing?
    (d) What harms are associated with additional testing following 
anatomic tests?
    (e) Is there differential effectiveness or harm based on patient 
characteristics (e.g., sex, age, comorbidities)?
    2. For patients considered to be at very low or low risk for CAD, 
what is the comparative effectiveness of functional tests (compared 
with each other, standard of care, or no testing):
    (f) For improving primary clinical health outcomes (e.g., quality 
of life, avoiding myocardial infarction)? In the absence of comparative 
studies linking testing with outcomes, do the tests predict future 
clinical events (predictive accuracy)?
    (g) What are the adverse effects, consequences or harms of testing?
    (h) How do noninvasive tests differ in terms of clinical management 
based on test results, including referral for coronary angiography or 
additional noninvasive testing?
    (i) What harms are associated with additional testing following 
anatomic tests?
    (j) Is there differential effectiveness or harm based on patient 
characteristics (e.g., sex, age, comorbidities) or the patient's 
ability to exercise?
    3. For patients considered to be at intermediate to high risk for 
CAD, what is the comparative effectiveness of anatomic tests (compared 
with each other standard of care, or no testing):
    (k) For improving primary clinical health outcomes (e.g., quality 
of life, avoiding myocardial infarction)? In the absence of comparative 
studies linking testing with outcomes, do the tests predict future 
clinical events (predictive accuracy)?
    (l) What are the adverse effects, consequences, or harms of 
testing?
    (m) How do noninvasive tests differ in terms of clinical management 
based on test results, including referral for coronary angiography or 
additional noninvasive testing?
    (n) What harms are associated with additional testing following 
anatomic tests?
    (o) Is there differential effectiveness or harm based on patient 
characteristics (e.g., sex, age, comorbidities)?
    4. For patients considered to be at intermediate to high risk for 
CAD, what is the comparative effectiveness of functional tests 
(compared with each other, standard of care, or no testing):
    (p) For improving primary clinical health outcomes (e.g., quality 
of life, avoiding myocardial infarction)? In the absence of comparative 
studies linking testing with outcomes, do the tests predict future 
clinical events (predictive accuracy)?
    (q) What are the adverse effects, consequences, or harms of 
testing?
    (r) How do noninvasive tests differ in terms of clinical management 
based on test results, including referral for coronary angiography or 
additional noninvasive testing?
    (s) What harms are associated with additional testing following 
anatomic tests?
    (t) Is there differential effectiveness or harm based on patient 
characteristics (e.g., sex, age, comorbidities) or the patient's 
ability to exercise?
    5. What is the comparative effectiveness of anatomic tests versus 
functional tests in those who are at very low or low risk for CAD?
    (u) For improving primary clinical health outcomes (e.g., quality 
of life, avoiding myocardial infarction)?
    (v) What are the adverse effects, consequences or harms of testing?
    (w) How do noninvasive tests differ in terms of clinical management 
based on test results, including referral for coronary angiography or 
additional noninvasive testing?
    (x) What harms are associated with additional testing following 
anatomic tests?
    (y) Is there differential effectiveness or harm based on patient 
characteristics (e.g., sex, age, comorbidities) or the patient's 
ability to exercise?
    6. What is the comparative effectiveness of anatomic tests versus 
functional tests in those who are at intermediate to high risk for CAD?

[[Page 3596]]

    (z) For improving primary clinical health outcomes (e.g., quality 
of life, avoiding myocardial infarction)?
    (aa) What are the adverse effects, consequences or harms of 
testing?
    (bb) How do noninvasive tests differ in terms of clinical 
management based on test results, including referral for coronary 
angiography or additional noninvasive testing?
    (cc) What harms are associated with additional testing following 
anatomic tests?
    (dd) Is there differential effectiveness or harm based on patient 
characteristics (e.g., sex, age, comorbidities) or the patient's 
ability to exercise?

PICOTS (Population, Intervention, Comparator, Outcome, Timing, Setting)

    Patient Population of Interest and Pre-Test Risk of CAD:
    The patient population is stable, symptomatic patients with 
suspected CAD who do not have previously diagnosed CAD and who have had 
a resting ECG. The definitions of risk categories are based on those 
described in the ACCF/AHA 2012 Guideline.\8\ In general, patient 
presentation and symptoms are primarily used to inform pre-test 
probability in the population of interest. The review will attempt to 
stratify studies based on these characteristics if definitions are not 
provided.
    <bullet> Include patients whose risk for CAD may be considered as 
follows:
    [cir] Those considered to be at very low or low risk of CAD based 
on having none or only one of the following:
    <bullet> Patient age and gender (female <65 years old, male <55 
years old)
    <bullet> Negative family history for CAD
    <bullet> <2 CAD risk factors (including hypertension, diabetes, 
smoking, dyslipidemia, metabolic syndrome)
    <bullet> New onset angina/chest pain (including noncardiac or 
atypical chest pain, angina equivalents, unstable angina without non-
ST-segment elevation myocardial infarction [NSTEMI], ST-segment 
elevation myocardial infarction [STEMI])
    <bullet> Normal or non-diagnostic resting ECG
    [cir] Those considered to be at intermediate to high risk of CAD 
based on having two or more of the following:
    <bullet> Patient age and gender (female >=65 years old, male >=55 
years old)
    <bullet> Positive family history for CAD
    <bullet> >=2 CAD risk factors (including hypertension, diabetes, 
smoking, dyslipidemia, metabolic syndrome)
    <bullet> New onset or progressive angina/chest pain or those with 
prolonged angina at rest (or relieved with rest or nitroglycerin) or 
nocturnal angina (angina including typical, atypical, definite, 
probable)
    <bullet> Possible ECG changes (e.g., T-wave, NSTEMI) or 
nondiagnostic ECG
    <bullet> Presence of other vascular disease (carotid disease, 
peripheral artery disease [PAD])
    <bullet> Exclude patients with any of the following 
characteristics:
    [cir] Unstable angina with elevated serum cardiac biomarkers, ECG 
changes, etc.
    [cir] Definite acute coronary syndrome (ACS), Non-ST-Elevation 
Acute Coronary Syndromes (NSTE-ACS), NSTEMI, STEMI
    [cir] Asymptomatic patients, including those being screened prior 
to surgery

Interventions

    This systematic review will focus on widely available noninvasive 
tests used for diagnosis of CAD or dysfunction that results in symptoms 
attributable to myocardial ischemia. Coronary artery calcium scoring 
has been included since it has been proposed primarily for its ability 
to exclude the presence of obstructive disease but not necessarily to 
confirm the presence of flow-limiting stenosis.
    Interventions for inclusion are:
    <bullet> Functional tests (including exercise, vasodilator and/or 
dobutamine as stressor where appropriate)
    [cir] Exercise electrocardiogram without imaging
    [cir] Exercise/pharmacologic echocardiography (with or without 
myocardial echo contrast)
    [cir] Exercise/pharmacologic cardiac nuclear imaging
    [cir] SPECT
    [cir] PET
    [cir] Pharmacologic stress MRI
    [cir] CT perfusion
    <bullet> Anatomic imaging
    [cir] Coronary calcium scoring via electron beam CT (EBCT) or 
multidetector CT (MDCT)
    [cir] CCTA

Comparators

    Comparisons between noninvasive tests included in the 
interventions; comparisons with no testing or standard of care. 
(Contextual information will be provided in the background only for 
comparisons of noninvasive tests with invasive coronary angiography 
with or without FFR and for comparison between noninvasive tests on 
traditional diagnostic test measures such as sensitivity and 
specificity.)

Outcomes

    <bullet> Clinical outcomes
    [cir] Quality of life (QOL)
    [cir] Change in angina (e.g., worsening)
    [cir] MI
    [cir] Heart failure
    [cir] Stroke
    [cir] Death
    [cir] Hospitalization for cardiovascular events (acute coronary 
syndrome, heart failure, arrhythmias)
    [cir] Dysrhythmia
    <bullet> Intermediate outcomes
    [cir] Need for additional testing (including referral for invasive 
testing)
    [cir] Management based on revised post-test risk stratification, 
including:
    <bullet> Guideline-directed medical therapy (GDMT), including 
management of lipids, blood pressure, and diabetes; counseling related 
to diet, physical activity, smoking cessation, alcohol use, and 
management of psychological factors; use of additional therapies to 
reduce risk of MI and death (e.g., antiplatelet therapy).
    <bullet> Any need for subsequent revascularization (percutaneous 
coronary intervention [PCI] or coronary artery bypass grafting [CABG])
    <bullet> Harms, risks and consequences of testing
    [cir] Procedural harms, adverse events of testing (e.g., renal 
failure, allergy, nephrogenic systemic fibrosis, contrast-related 
harms, adverse reactions to drugs for stress tests), vascular 
complications
    [cir] Consequences of testing (e.g., radiation exposure, 
psychological consequences, consequences of additional testing or 
incidental findings)

Setting

    Nonemergent inpatient settings or ambulatory/outpatient settings, 
including emergency department.

Timing

    At time of first test for evaluation using a noninvasive test other 
than resting ECG.

    Dated: December 29, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2015-00763 Filed 1-22-15; 8:45 am]
BILLING CODE 4160-90-M


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