Enhanced Detection of Underlying, Covert ATrial Fibrillation Using 7-day Holter Electrocardiogram in Patients With Embolic Stroke of Undetermined Source

Study Overview
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Brief Summary
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The aim of this study is to determine the diagnostic yield of continuous 7-day Holter ECG for detecting covert paroxysmal atrial fibrillation in patients with recent embolic stroke or transient ischemic attack (TIA) of undetermined cause after completion of a standard clinical work up including an initial 24-hour Holter monitoring.

Detailed Description
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Covert atrial fibrillation (AF) is a relevant potential cause of a recently proposed clinical construct, Embolic Stroke of Undetermined Source (ESUS). However, routine post-stroke work up including 24-hour Holter monitoring may fail to detect paroxysmal AF. A recent systematic review has shown an increased AF detection rate with longer monitoring durations. The aim of this study is to evaluate the effectiveness of a novel ambulatory 7-day Holter ECG (EV-201, Parama-Tech inc.) for detecting AF in patients with recent ESUS after completion of a standard clinical examination.

Conditions
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Stroke

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recent ESUS (within 3 months of onset) defined as: A. Recent ischemic stroke (including transient ischemic attack with positive neuroimaging) visualized by brain imaging that is not lacunar B. Abscence of ≥ 50% stenosis or occlusion in cervical and intracranial arteries supplying ischemic area C. No atrial fibrillation after ≥ 24-hour Holter monitoring D. No intra-cardiac thrombus on transthoracic echocardiography E. No other major cardioembolic sources F. No other specific cause of stroke (for example, arteritis, dissection, migraine/vasospasm, drug abuse) 20 years of age or older Signed written informed consent Exclusion Criteria: Previously documented atrial fibrillation Untreated hyperthyroidism Pacemaker or implantable cardioverter defibrillator implanted or planned to implant Estimated life expectancy < 12 months Examination of seven-day Holter ECG not applicable within 3 months after stroke onset. Patients considered inappropriate to participate in the study

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of any atrial fibrillation |  | After examination of 7-day Holter monitoring (within 90 days of stroke onset) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of antithrombotic drugs |  | After the examination of 7-day Holter monitoring | 
| Any ischemic or hemorrhagic event |  | 365 days after index stroke | 
| Any adverse event related to 7-day Holter monitoring |  | After the examination of 7-day Holter monitoring | 
| Time to detection of atrial fibrillation on 7-day Holter monitoring |  | After the examination of 7-day Holter monitoring | 
| Atrial fibrillation burden | defined as the total time in atrial fibrillation devided by the total monitored time | After the examination of 7-day Holter monitoring | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Embolic stroke of undetermined source, Atrial fibrillation