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

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH402 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

402

Conditions

Stroke

Interventions

prolonged ECG monitoringOTHER

10-day Holter ECG measurement

standard careOTHER

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

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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.

Locations (4)

Dept. of Cardiology and Pneumology, University Medical Center Goettingen

Göttingen, Germany

Clinic and Policlinic for Neurology, University of Mainz

Mainz, Germany

Dept. of Neurology, Nordwest-Hospital Sanderbusch

Sande, Germany

Dept. of Neurology, HSK, Dr. Horst-Schmidt-Hospital

Wiesbaden, Germany

Outcomes

Primary Outcomes

number of atrial fibrillation/flutter

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.

Time frame: 30 month after study start

Secondary Outcomes

number of atrial fibrillation (/flutter) within 12 months after patient's inclusion

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.

Time frame: 24 months after study start

number of atrial fibrillation (/flutter) without hospitalisation

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.

Time frame: 30 months after study start

number of recurrent stroke or systemic embolism

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.

Time frame: 24 months after study start

total mortality

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.

Time frame: 24 months after study start

number of cardiovascular deaths

Time frame: 24 months after study start

Data from ClinicalTrials.gov

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