Atrial fibrillation is the most common cardiac cause of ischemic stroke. Detecting atrial fibrillation after a stroke or TIA is critical because highly effective secondary stroke prevention therapy is available for individuals who are recognized to have atrial fibrillation. However, atrial fibrillation is likely under-diagnosed after stroke and TIA because atrial fibrillation is often difficult to detect as it is frequently paroxysmal and asymptomatic, and patients do not routinely undergo prolonged screening. The purpose of this study is to determine the diagnostic yield of a novel 30-day cardiac event monitor compared to a repeat 24-hour Holter monitor for detecting occult paroxysmal atrial fibrillation in patients with a recent ischemic stroke or TIA of undetermined etiology after completion of a standard clinical stroke work-up (including an initial negative Holter monitor.)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
564
Patients will be fitted with dry electrode belt (including cardiac event monitor)and instructed to wear the device for as many hours(waking and sleeping) each day as possible, for a total of 30 days.
Repeat standard 24-hour Holter Monitor
Foothills Medical Centre
Calgary, Alberta, Canada
Grey Nuns Hospital
Edmonton, Alberta, Canada
Walter C. Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada
Vancouver Hospital and Health Sciences Centre
Vancouver, British Columbia, Canada
Vancouver Island Health Research Centre (VIHA)
Victoria, British Columbia, Canada
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Robarts Research Institute
London, Ontario, Canada
Ottawa Hospital Research Institute -The Ottawa Hospital
Ottawa, Ontario, Canada
...and 7 more locations
Detection of one or more episodes of atrial fibrillation or atrial flutter ≥30 seconds, as assessed at the 90 day follow-up
Time frame: 90 days
Atrial fibrillation <30 seconds
Time frame: 90 days
Atrial flutter <30 seconds
Time frame: 90 days
Non-sustained (>3 beats, <30 seconds) irregular atrial tachyarrhythmia (including brief runs of atrial fibrillation)
Time frame: 90 days
Proportion of patients in each group that are prescribed oral anticoagulation, as assessed at the 90-day follow-up
Time frame: 90 days
Patient adherence with 30-day monitoring: average proportion of days wearing the monitor per patient, and the percentage of patients wearing the monitor for >75% of the target period
Time frame: 90 days
1 and 2-year recurrence of ischemic stroke/TIA, death, hemorrhagic stroke, major adverse bleeding event, detection of atrial fibrillation outside of the study protocol
Time frame: 2 years
composite endpoint of: (1) AF >30 seconds, (2) non-sustained (>3 beats, <30 seconds) irregular atrial tachyarrhythmia (including brief runs of AF), or (3) atrial flutter.
Time frame: 90 days
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