Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin

Completed · Not applicable

Conditions studied: Stroke, Acute

In brief

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.

Key facts

Study ID

NCT02700945

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

496

Starts

2016-03-01

Expected to finish

2022-07-28

Last updated by the study team

2023-05-26

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Cardiovascular Associates of the Southeast — Birmingham, Alabama, United States
• Scripps Memorial Hospital La Jolla — La Jolla, California, United States
• University of California San Francisco UCSF Medical Center — San Francisco, California, United States
• Innovative Medical Research of South Florida — Aventura, Florida, United States
• University of Miami Hospital — Miami, Florida, United States
• AdventHealth Neuroscience Institute — Orlando, Florida, United States
• The Queens Medical Center — Honolulu, Hawaii, United States
• Northwestern University — Chicago, Illinois, United States
• Baptist Health Lexington — Lexington, Kentucky, United States
• Norton Neuroscience Institute — Louisville, Kentucky, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Health Partners Institute (Bloomington MN) — Bloomington, Minnesota, United States
• Health Partners Institute (Saint Louis Park MN) — Saint Louis Park, Minnesota, United States
• Cox Medical Center South — Springfield, Missouri, United States
• Mercy Clinic Cardiology — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Albany Medical Center — Albany, New York, United States
• University at Buffalo, The State University of New York — Buffalo, New York, United States
• North Shore University Hospital — New Hyde Park, New York, United States
• NYU Langone Medical Center — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Overlook Medical Center — Summit, New York, United States
• Cone Health — Greensboro, North Carolina, United States
• The University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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