Clinical trial NCT02700945: Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin
Official title: Stroke AF - Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2016-03-07
Enrollment: 496
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized 1:1 to the continuous monitoring arm or the control arm. Subjects randomized to the continuous monitoring arm will have a Reveal LINQ ICM inserted within 10 days of the qualifying stroke and undergo continuous remote monitoring. Subjects randomized to the control arm will be followed per site specific standard of care.
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the Stroke AF study is to compare the incidence of atrial fibrillation (AF) through 12 months between continuous cardiac rhythm monitoring with the Reveal LINQ™ Insertable Cardiac Monitor (ICM) (continuous monitoring arm) and standard of care (SoC) medical treatment (control arm) in subjects with a recent ischemic stroke of presumed known origin.

Detailed description: Stroke AF is a prospective, multi-site, randomized, controlled, non-blinded, post-market study. The Stroke AF study will compare the incidence rate of atrial fibrillation through 12 months between the continuous monitoring arm and the control arm in subjects with a recent ischemic stroke of presumed known origin. Subjects randomized to the continuous monitoring arm will have a Reveal LINQ Insertable Cardiac Monitor inserted within 10 days of the qualifying stroke and undergo continuous remote monitoring. Subjects randomized to the control arm will be followed per site specific standard of care.

Eligibility criteria: Inclusion Criteria:

* Subject has had an ischemic stroke believed to be due to small vessel disease, large vessel cervical or intracranial atherosclerosis within the past 10 days
* Subject is willing and able to undergo study requirements and expected to be geographically stable during study follow-up
* Subject is 60 years of age or older, or age 50 to 59 years plus a documented medical history of at least one of the following additional risk factors for stroke:

  * Congestive heart failure
  * Hypertension (Systolic Blood Pressure \> 140)
  * Diabetes Mellitus
  * Prior Stroke (\>90 days ago, other than study qualifying index event)
  * Vascular disease (e.g. coronary artery disease, heart attack, peripheral artery disease and complex aortic plaque)

Exclusion Criteria:

* Subject has had a cryptogenic stroke
* Subject has had a cardioembolic stroke
* Subject has untreated hyperthyroidism
* Subject has had a recent myocardial infarction \<1 month of stroke
* Subject has had a recent cardiac surgery (e.g. coronary artery bypass surgery (CABG)) \<1 month of stroke
* Subject has a mechanical heart valve
* Subject has valvular disease requiring immediate surgical intervention
* Subject has documented prior history of atrial fibrillation or atrial flutter
* Subject has permanent indication for oral anticoagulation
* Subject has permanent contraindication to oral anticoagulation such that detection of AF would not change medical management, based on enrolling investigators judgment
* Subject is enrolled in a concurrent study that may confound the results of this study. Co-enrollment in any concurrent clinical study (including registries) requires approval of the study manager or designee.
* Subject's life expectancy is less than 1 year
* Subject is pregnant
* Subject has or is indicated for implant with a pacemaker, Implantable Cardioverter Defibrillator (ICD), Cardiac ResynchronizationTherapy (CRT), or an implantable hemodynamic monitor
* Subject with a medical condition that precludes the patient from participation in the opinion of the investigator

Primary outcomes:
measure: The Rate of AF Through 12 Months in Subjects With a Recent Ischemic Stroke of Presumed Known Origin.
timeFrame: 12 months
Secondary outcomes:
measure: The Rate of AF Through the Duration of Study Follow-up (36 Months) Between Study Arms.
timeFrame: 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiovascular Associates of the Southeast
state: Alabama
city: La Jolla
country: United States
facility: Scripps Memorial Hospital La Jolla
state: California
city: San Francisco
country: United States
facility: University of California San Francisco UCSF Medical Center
state: California
city: Aventura
country: United States
facility: Innovative Medical Research of South Florida
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Orlando
country: United States
facility: AdventHealth Neuroscience Institute
state: Florida
city: Honolulu
country: United States
facility: The Queens Medical Center
state: Hawaii
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Louisville
country: United States
facility: Norton Neuroscience Institute
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Bloomington
country: United States
facility: Health Partners Institute (Bloomington MN)
state: Minnesota
city: Saint Louis Park
country: United States
facility: Health Partners Institute (Saint Louis Park MN)
state: Minnesota
city: Saint Louis
country: United States
facility: Mercy Clinic Cardiology
state: Missouri
city: Springfield
country: United States
facility: Cox Medical Center South
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Buffalo
country: United States
facility: University at Buffalo, The State University of New York
state: New York
city: New Hyde Park
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Summit
country: United States
facility: Overlook Medical Center
state: New York
city: Greensboro
country: United States
facility: Cone Health
state: North Carolina
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center
state: Oklahoma
city: Springfield
country: United States
facility: PeaceHealth Sacred Heart Medical Center at Riverbend
state: Oregon
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Institute for Medical Research
state: Pennsylvania
city: Nashville
country: United States
facility: Saint Thomas Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Baylor Research Institute Dallas - Baylor University Medical Center (BUMC)
state: Texas
city: Dallas
country: United States
facility: University of Texas (UT) Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Lynchburg
country: United States
facility: Centra Medical Group Stroobants Cardiovascular Center
state: Virginia
city: Milwaukee
country: United States
facility: Aurora Saint Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: Northwestern University
name: Richard Bernstein, PhD/MD
role: STUDY_CHAIR
affiliation: Mass General
name: Lee Schwamm, MD
role: STUDY_CHAIR
References:
citation: Schwamm LH, Kamel H, Granger CB, Piccini JP, Katz JM, Sethi PP, Sidorov EV, Kasner SE, Silverman SB, Merriam TT, Franco N, Ziegler PD, Bernstein RA; STROKE AF Investigators. Predictors of Atrial Fibrillation in Patients With Stroke Attributed to Large- or Small-Vessel Disease: A Prespecified Secondary Analysis of the STROKE AF Randomized Clinical Trial. JAMA Neurol. 2023 Jan 1;80(1):99-103. doi: 10.1001/jamaneurol.2022.4038.
citation: Zachrison KS, Amati V, Schwamm LH, Yan Z, Nielsen V, Christie A, Reeves MJ, Sauser JP, Lomi A, Onnela JP. Influence of Hospital Characteristics on Hospital Transfer Destinations for Patients With Stroke. Circ Cardiovasc Qual Outcomes. 2022 May;15(5):e008269. doi: 10.1161/CIRCOUTCOMES.121.008269. Epub 2022 Apr 4.
citation: Bernstein RA, Kamel H, Granger CB, Piccini JP, Sethi PP, Katz JM, Vives CA, Ziegler PD, Franco NC, Schwamm LH; STROKE-AF Investigators. Effect of Long-term Continuous Cardiac Monitoring vs Usual Care on Detection of Atrial Fibrillation in Patients With Stroke Attributed to Large- or Small-Vessel Disease: The STROKE-AF Randomized Clinical Trial. JAMA. 2021 Jun 1;325(21):2169-2177. doi: 10.1001/jama.2021.6470.