Screening for Atrial Fibrillation, After Ischemic Stroke

NCT ID: NCT01160406

Last Updated: 2011-06-27

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

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-11-30

Brief Summary

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The aim of the study is to assess the incidence of patients suffering from ischemic stroke or transient ischemic attacks who have underlying asymptomatic paroxysmal atrial fibrillation.

Patients who have suffered an ischemic stroke or transient ischemic attack, without a history of atrial fibrillation, are planned to be included. Starting within 14 days of the ischemic stroke, participating patients are asked to perform 10 second ECG recordings using a handheld ECG device twice daily (mornings and evenings) during 30 days. These recordings are transmitted via telephone to a secure encrypted Internet site. Within these 30 days the participants also perform an ambulatory 24 hour Holter recording. Handheld ECG recordings are evaluated continuously. In case of atrial fibrillation the patient is informed and offered treatment with anti coagulant medication (Warfarin). The investigation is a comparison between 24 hour continuous ECG recordings and short intermittent ECG recordings twice daily over a longer time period to determine which method is the best to detect atrial fibrillation in this patient group.

Hypothesis: Short Intermittent ECG recordings over a longer time period is more efficient, compared with continuous 24 hour ECG recordings, in detecting silent paroxysmal AF in patients with an ischemic stroke and without a history of atrial fibrillation.

Detailed Description

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Conditions

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Atrial Fibrillation Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ischemic stroke, no atrial fibrillation

Patients who have suffered ischemic stroke or transient ischemic attack without known atrial fibrillation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* No previously diagnosed atrial fibrillation.
* Acute ischemic stroke or transient ischemic attack verified by computed tomography or clinical diagnosis using the National Institute of Health Stroke Score within 14 days of enrollment.
* Ability to understand study instructions both verbal and written.
* Ability to perform and transmit ECG recordings according to study design.

Exclusion Criteria

* Previously diagnosed atrial fibrillation.
* Hemorrhagic stroke
* Low compliance
* Pacemaker carrier
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Karolinska Institutet

Principal Investigators

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MÃ¥rten Rosenqvist, M.D.Ph.D.

Role: STUDY_DIRECTOR

Karolinska Institutet

Locations

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Halmstad hospital

Halmstad, Halland County, Sweden

Site Status

South hospital

Stockholm, Stockholm County, Sweden

Site Status

Danderyds hospital AB

Stockholm, Stockholm County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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KI-DSAB-2010

Identifier Type: -

Identifier Source: org_study_id

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