Impact of Standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke

N/ACompletedNCT02204267

Charite University, Berlin, Germany3,470 enrolled

Overview

Investigator-initiated prospective randomized multicentre study to uncover the true burden of paroxysmal atrial fibrillation in a representative population of acute stroke patients without known atrial fibrillation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

3,470

Conditions

Stroke Atrial Fibrillation

Interventions

prolonged ECG monitoringOTHER

Start of long-term ECG immediately after admission to the stroke unit by using a portable ECG recorder for a max. duration of 7 days (or hospital discharge)

ECGDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Acute ischemic stroke or transitory ischemic attack (with clinical deficit on enrolment or MRI detected acute brain lesion on admission) * Age ≥ 18 years * Written or oral informed consent * Stroke unit admission within 72 hours after stroke onset * Start of standardized prolonged ECG monitoring within 24 hours after admission to the stroke unit * Willingness to take part in the planned follow up examinations Exclusion Criteria: * Known atrial fibrillation * Atrial fibrillation detected by ECG on admission * Atrial fibrillation detected prior study enrollment on the stroke unit * Life expectancy \< 1 year (before actual stroke) * Life expectancy \< 1 month (after actual stroke) * Indication for oral anticoagulation other than atrial fibrillation (e.g. mechanical heart valve) * Severity level according National Institute of Health Stroke Scale (NIHSS) score \> 22 * Participation in an interventional trial

Locations (1)

Charité Universitaetsmedizin Berlin

Berlin, Germany

Outcomes

Primary Outcomes

Number of patients on oral anticoagulation (NOAC or VKA)

Number of study patients on oral anticoagulation (NOAC or VKA) at 12 months after the index stroke either randomized to standardized prolonged ECG monitoring in-hospital or those randomized to usual stroke unit diagnostic procedures alone.

Time frame: 12 months

Secondary Outcomes

Number of stroke patients with newly detected atrial fibrillation

Number of stroke patients with newly detected atrial fibrillation using a standardized prolonged ECG monitoring compared to usual stroke unit diagnostic procedures alone.

Time frame: 7 days

Data from ClinicalTrials.gov

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