Status:
COMPLETED
Finding Atrial Fibrillation in Stroke - Evaluation of Enhanced and Prolonged Holter Monitoring
Lead Sponsor:
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Conditions:
Stroke
Eligibility:
All Genders
60+ years
Phase:
NA
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 ca...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT01855035
Start Date
May 1 2013
End Date
November 1 2017
Last Update
May 4 2020
Active Locations (4)
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1
Dept. of Cardiology and Pneumology, University Medical Center Goettingen
Göttingen, Germany, 37075
2
Clinic and Policlinic for Neurology, University of Mainz
Mainz, Germany, 55131
3
Dept. of Neurology, Nordwest-Hospital Sanderbusch
Sande, Germany, 26452
4
Dept. of Neurology, HSK, Dr. Horst-Schmidt-Hospital
Wiesbaden, Germany, 65199