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Screening for Atrial Fibrillation, After Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT01160406
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
Karolinska Institutet

Brief Summary:

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.


Condition or disease
Atrial Fibrillation Stroke

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Screening for Silent Atrial Fibrillation, After Ischemic Stroke
Study Start Date : June 2007
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
ischemic stroke, no atrial fibrillation
Patients who have suffered ischemic stroke or transient ischemic attack without known atrial fibrillation




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from hospital strokewards.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01160406


Locations
Sweden
Halmstad hospital
Halmstad, Halland, Sweden, 30180
South hospital
Stockholm, Sweden, 11883
Danderyds hospital AB
Stockholm, Sweden, 18288
Sponsors and Collaborators
Karolinska Institutet
Investigators
Study Director: Mårten Rosenqvist, M.D.Ph.D. Karolinska Institutet

Responsible Party: Mårten Rosenqvist M.D. Ph.D., Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01160406     History of Changes
Other Study ID Numbers: KI-DSAB-2010
First Posted: July 12, 2010    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011

Keywords provided by Karolinska Institutet:
silent paroxysmal atrial fibrillation
stroke
tele ECG

Additional relevant MeSH terms:
Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes