Impact of Standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke

Study Overview
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Brief Summary
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Investigator-initiated prospective randomized multicentre study to uncover the true burden of paroxysmal atrial fibrillation in a representative population of acute stroke patients without known atrial fibrillation.

Official Title
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Impact of Standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke

Conditions
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Stroke, Atrial Fibrillation

Intervention / Treatment
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* Other: prolonged ECG monitoring
* Device: ECG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute ischemic stroke or transitory ischemic attack (with clinical deficit on enrolment or MRI detected acute brain lesion on admission) Age ≥ 18 years Written or oral informed consent Stroke unit admission within 72 hours after stroke onset Start of standardized prolonged ECG monitoring within 24 hours after admission to the stroke unit Willingness to take part in the planned follow up examinations Exclusion Criteria: Known atrial fibrillation Atrial fibrillation detected by ECG on admission Atrial fibrillation detected prior study enrollment on the stroke unit Life expectancy < 1 year (before actual stroke) Life expectancy < 1 month (after actual stroke) Indication for oral anticoagulation other than atrial fibrillation (e.g. mechanical heart valve) Severity level according National Institute of Health Stroke Scale (NIHSS) score > 22 Participation in an interventional trial

Ages Eligible for Study
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Minimum Age: 18 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prolonged ECG monitoring<br>Regular stroke unit treatment and diagnostic procedures according to guidelines and additional prolonged ECG monitoring | Other: prolonged ECG monitoring<br>* Start of long-term ECG immediately after admission to the stroke unit by using a portable ECG recorder for a max. duration of 7 days (or hospital discharge)<br>Device: ECG<br> <br> |
| No Intervention: no additional ECG recording<br>Regular stroke unit treatment and diagnostic procedures according to guidelines | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients on oral anticoagulation (NOAC or VKA) | Number of study patients on oral anticoagulation (NOAC or VKA) at 12 months after the index stroke either randomized to standardized prolonged ECG monitoring in-hospital or those randomized to usual stroke unit diagnostic procedures alone. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of stroke patients with newly detected atrial fibrillation | Number of stroke patients with newly detected atrial fibrillation using a standardized prolonged ECG monitoring compared to usual stroke unit diagnostic procedures alone. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, atrial fibrillation, ECG