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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2017-11-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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prolonged ECG monitoring

Prolonged ECG monitoring: 10-day Holter ECG at months 0, 3 and 6

Group Type EXPERIMENTAL

prolonged ECG monitoring

Intervention Type OTHER

10-day Holter ECG measurement

standard care

Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).

Group Type OTHER

standard care

Intervention Type OTHER

Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).

Interventions

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prolonged ECG monitoring

10-day Holter ECG measurement

Intervention Type OTHER

standard care

Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No