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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: prolonged ECG monitoring; Other: standard care

• Registration Number: NCT01855035
• Lead Sponsor: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-05-15
• Study First Posted: 2013-05-16
• Primary Completion: 2017-09
• Study Completion: 2017-11
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-30
• Last Update Posted: 2020-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 402

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prolonged ECG monitoring	prolonged ECG monitoring	Prolonged ECG monitoring: 10-day Holter ECG at months 0, 3 and 6
standard care	standard care	Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).

Primary Outcome Measures

Name	Time	Method
number of atrial fibrillation/flutter	30 month after study start	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.

Secondary Outcome Measures

Name	Time	Method
number of atrial fibrillation (/flutter) without hospitalisation	30 months after study start	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.
number of recurrent stroke or systemic embolism	24 months after study start	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.
total mortality	24 months after study start	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.
number of atrial fibrillation (/flutter) within 12 months after patient's inclusion	24 months after study start	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.
number of cerebrovascular deaths	24 months after study start
quality of life	24 months after study start
number of cardiovascular 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
number of atrial fibrillation (/flutter) in extended monitoring period	24 months after study start	Incremental detection of atrial fibrillation (/flutter) in the extended Holter monitoring periods after 3 and 6 months.
costs	24 months after study start
number of correct monitorings	24 months after study start	To assess the feasibility of monitoring procedures.

Trial Locations

Locations (4)

Dept. of Cardiology and Pneumology, University Medical Center Goettingen; 🇩🇪 Goettingen, Germany

Dept. of Neurology, Nordwest-Hospital Sanderbusch; 🇩🇪 Sande, Germany

Dept. of Neurology, HSK, Dr. Horst-Schmidt-Hospital; 🇩🇪 Wiesbaden, Germany

Clinic and Policlinic for Neurology, University of Mainz; 🇩🇪 Mainz, Germany