Atrial Fibrillation, Stroke
Conditions
Keywords
Stroke, atrial fibrillation, ECG
Brief summary
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.
Interventions
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)
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients on oral anticoagulation (NOAC or VKA) | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of stroke patients with newly detected atrial fibrillation | 7 days | Number of stroke patients with newly detected atrial fibrillation using a standardized prolonged ECG monitoring compared to usual stroke unit diagnostic procedures alone. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Impact of stroke unit level on the rate of atrial fibrillation detection | 7 days | Impact of stroke unit level (i.e. primary or comprehensive stroke center) on the rate of atrial fibrillation detection in-hospital stroke in patients randomized to standardized prolonged ECG monitoring in hospital |
| Number of recurrent strokes, major bleeds, myocardial infarction and all-cause death (composite endpoint) within 6, 12 and 24 months after the index stroke | 24 months | Number of recurrent strokes, major bleeds, myocardial infarction and all-cause death (composite endpoint) within 6, 12 and 24 months after the index stroke in patients either randomized to standardized prolonged ECG monitoring in-hospital or those randomized to usual stroke unit diagnostic procedures alone. |
Countries
Germany