Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin
Stroke AF - Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin
1 other identifier
interventional
496
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2016
Longer than P75 for not_applicable
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 2, 2016
CompletedFirst Posted
Study publicly available on registry
March 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2020
CompletedResults Posted
Study results publicly available
November 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2022
CompletedMay 26, 2023
April 1, 2023
4.4 years
March 2, 2016
August 5, 2021
April 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The Rate of AF Through 12 Months in Subjects With a Recent Ischemic Stroke of Presumed Known Origin.
AF will be defined as an AF event lasting more than 30 seconds. The first AF episode detected and adjudicated by the endpoint adjudication committee will be used for this analysis.
12 months
Secondary Outcomes (1)
The Rate of AF Through the Duration of Study Follow-up (36 Months) Between Study Arms.
3 years
Study Arms (2)
Reveal LINQ™ Insertable Cardiac Monitor
ACTIVE COMPARATORSubjects randomized to the Reveal LINQ™ Insertable Cardiac Monitor arm will be continuously monitored via the inserted Reveal LINQ™ device.
Control Arm
NO INTERVENTIONSubjects randomized to the control arm will be followed per site specific standard of care.
Interventions
The Medtronic Reveal LINQ™ ICM is a programmable device that continuously monitors a patient's ECG (electrocardiogram) and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient activation.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Cardiovascular Associates of the Southeast
Birmingham, Alabama, 35243, United States
Scripps Memorial Hospital La Jolla
La Jolla, California, 92037, United States
University of California San Francisco UCSF Medical Center
San Francisco, California, 94143, United States
Innovative Medical Research of South Florida
Aventura, Florida, 33180, United States
University of Miami Hospital
Miami, Florida, 33136, United States
AdventHealth Neuroscience Institute
Orlando, Florida, 32803, United States
The Queens Medical Center
Honolulu, Hawaii, 96813, United States
Northwestern University
Chicago, Illinois, 60611, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Norton Neuroscience Institute
Louisville, Kentucky, 40202, United States
Ochsner Medical Center
New Orleans, Louisiana, 70201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Health Partners Institute (Bloomington MN)
Bloomington, Minnesota, 55101, United States
Health Partners Institute (Saint Louis Park MN)
Saint Louis Park, Minnesota, 55426, United States
Cox Medical Center South
Springfield, Missouri, 65807, United States
Mercy Clinic Cardiology
St Louis, Missouri, 63141, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Albany Medical Center
Albany, New York, 12211, United States
University at Buffalo, The State University of New York
Buffalo, New York, 14203, United States
North Shore University Hospital
New Hyde Park, New York, 11030, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Overlook Medical Center
Summit, New York, 07901, United States
Cone Health
Greensboro, North Carolina, 27401, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
PeaceHealth Sacred Heart Medical Center at Riverbend
Springfield, Oregon, 97477, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17604, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096, United States
Saint Thomas Research Institute
Nashville, Tennessee, 37205, United States
Baylor Research Institute Dallas - Baylor University Medical Center (BUMC)
Dallas, Texas, 75246, United States
University of Texas (UT) Southwestern Medical Center
Dallas, Texas, 75390, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Centra Medical Group Stroobants Cardiovascular Center
Lynchburg, Virginia, 24501, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Related Publications (4)
Bernstein RA, Kamel H, Granger CB, Piccini JP, Katz JM, Sethi PP, Pouliot E, Franco N, Ziegler PD, Schwamm LH; STROKE AF Investigators. Atrial Fibrillation In Patients With Stroke Attributed to Large- or Small-Vessel Disease: 3-Year Results From the STROKE AF Randomized Clinical Trial. JAMA Neurol. 2023 Dec 1;80(12):1277-1283. doi: 10.1001/jamaneurol.2023.3931.
PMID: 37902733DERIVEDSchwamm 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.
PMID: 36374508DERIVEDZachrison 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.
PMID: 35369714DERIVEDBernstein 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.
PMID: 34061145DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The attribution of stroke mechanism is subjective and may have led to the enrollment of a population at higher risk of underlying embolism. However, this attribution reflects real-world practice and our sample is representative of patients in whom ICM decisions need to be made. The assignment to ICM versus control was not blinded, however our study endpoint was adjudicated using objective criteria. Our study was not powered to detect a significant difference in rates of recurrent stroke.
Results Point of Contact
- Title
- Carola Alfaro Vives
- Organization
- Medtronic
Study Officials
- STUDY CHAIR
Richard Bernstein, PhD/MD
Northwestern University
- STUDY CHAIR
Lee Schwamm, MD
Mass General
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2016
First Posted
March 7, 2016
Study Start
March 1, 2016
Primary Completion
August 3, 2020
Study Completion
July 28, 2022
Last Updated
May 26, 2023
Results First Posted
November 9, 2021
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share
This data is for internal, Medtronic use only. Data from the study will be analyzed and submitted in the form of abstracts and possible publication in a journal.