Stoke AF

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In response to the COVID pandemic, Scripps Health has temporarily suspended enrollment for all clinical trials. Exceptions will exist for trials with curative intent, life-saving treatment or when no standard of care exists. For questions, please call Scripps Office for the Protection of Research Subjects at 858-678-6402.

Trial ID:
Mary Kalafut
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.

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

Why isn't this trial accepting new patients?

The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting

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How can I find trials that are accepting new participants?

For more information, see a list of trials that are recruiting, or call the clinical research office at 858-648-6402 for help.