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

Not Applicable

Completed

• Conditions: Stroke; Atrial Fibrillation
• Interventions: Other: prolonged ECG monitoring; Device: ECG

• Registration Number: NCT02204267
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-07-29
• Study First Posted: 2014-07-30
• Study Start: 2014-12
• Primary Completion: 2020-05
• Study Completion: 2020-10
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-11
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3470

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prolonged ECG monitoring	ECG	Regular stroke unit treatment and diagnostic procedures according to guidelines and additional prolonged ECG monitoring
prolonged ECG monitoring	prolonged ECG monitoring	Regular stroke unit treatment and diagnostic procedures according to guidelines and additional prolonged ECG monitoring

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Charité Universitaetsmedizin Berlin; 🇩🇪 Berlin, Germany