Finding Atrial Fibrillation in Stroke - Evaluation of Enhanced and Prolonged Holter Monitoring

Study Overview
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Brief Summary
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The purpose of this study is to assess whether repeated enhanced and prolonged ECG monitoring after ischemic stroke results in a higher detection of atrial fibrillation (/flutter) compared to usual care (at least 24 hour of cardiac monitoring).

Official Title
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A Prospective, Randomised, Controlled Study to Determine the Detection of Atrial Fibrillation by Prolonged and Enhanced Holter Monitoring as Compared to Usual Care in Stroke Patients

Conditions
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Stroke

Intervention / Treatment
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* Other: prolonged ECG monitoring
* Other: standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recent cerebral ischemia defined as stroke (sudden focal neurologic deficit lasting > 24h consistent with the territory of a major cerebral artery and categorised as ischemic) and/or a corresponding lesion on brain imaging. Stroke symptoms started ≤ 7 days ago. Age ≥ 60 years. Modified Rankin scale ≤ 2 (prior to index event). Exclusion Criteria: Known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ECG. Indication for oral anticoagulation at randomisation. Absolute contra-indication against oral anticoagulation at randomisation. Intracerebral bleeding in medical history. Patient scheduled for Holter-ECG or cardiac Event-Recording monitoring ≥ 48 hours. Significant carotid artery or vertebral artery stenosis > 50% (NASCET classification), significant intracranial artery stenosis suspicious of atherosclerotic origin or acute arterial dissection explanatory of stroke symptoms. Implanted pacemaker device or cardioverter/defibrillator. Life expectancy < 1 year for reasons other than stroke (e.g. metastatic cancer). Concomitant participation in other controlled randomised trial.

Ages Eligible for Study
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Minimum Age: 60 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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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prolonged ECG monitoring<br>Prolonged ECG monitoring: 10-day Holter ECG at months 0, 3 and 6 | Other: prolonged ECG monitoring<br>* 10-day Holter ECG measurement<br>|
| Other: standard care<br>Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring). | Other: standard care<br>* Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of atrial fibrillation/flutter | The primary endpoint is the detection of newly diagnosed atrial fibrillation/flutter within 6 months and before occurrence of recurrent stroke or systemic embolism in the treatment group compared to control group. | 30 month after study start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of atrial fibrillation (/flutter) within 12 months after patient's inclusion | Detection of newly diagnosed atrial fibrillation (/flutter) as defined for the primary endpoint but within 12 months after patient's inclusion. As patients are recruited for 12 months, this outcome measure is determined 24 months after study start. | 24 months after study start | 
| number of atrial fibrillation (/flutter) without hospitalisation | Detection of newly diagnosed atrial fibrillation (/flutter) as defined for the primary endpoint with the exception that hospitalisation for atrial fibrillation (/flutter) will be considered as censoring. | 30 months after study start | 
| number of recurrent stroke or systemic embolism | Recurrent stroke or systemic embolism within 12 months after patient's inclusion. As patients are recruited for 12 months, this outcome measure is determined 24 months after study start. | 24 months after study start | 
| total mortality | Total death within 12 months after patient's inclusion. As patients are recruited for 12 months, this outcome measure is determined 24 months after study start. | 24 months after study start | 
| number of cardiovascular deaths |  | 24 months after study start | 
| number of cerebrovascular deaths |  | 24 months after study start | 
| number of transient ischemic attacks |  | 24 months after study start | 
| number of myocardial infarctions |  | 24 months after study start | 
| number of bleeding complications |  | 24 months after study start | 
| quality of life |  | 24 months after study start | 
| number of atrial fibrillation (/flutter) in extended monitoring period | Incremental detection of atrial fibrillation (/flutter) in the extended Holter monitoring periods after 3 and 6 months. | 24 months after study start | 
| costs |  | 24 months after study start | 
| number of correct monitorings | To assess the feasibility of monitoring procedures. | 24 months after study start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic stroke, ECG monitoring, atrial fibrillation (/flutter)