Finding Atrial Fibrillation in Stroke - Evaluation of Enhanced and Prolonged Holter Monitoring (NCT01855035) | Clinical Trial Compass
CompletedNot Applicable
Finding Atrial Fibrillation in Stroke - Evaluation of Enhanced and Prolonged Holter Monitoring
Germany402 participantsStarted 2013-05
Plain-language 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).
Who can participate
Age range60 Years
SexALL
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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.
What they're measuring
1
number of atrial fibrillation/flutter
Timeframe: 30 month after study start
Trial details
NCT IDNCT01855035
SponsorInstitut fuer anwendungsorientierte Forschung und klinische Studien GmbH