Atrial Fibrillation Incidence, Risk Factors and Genetics

Sponsor
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00021905
Collaborator
(none)
71

Study Details

Study Description

Brief Summary

To assess the risk of incident atrial fibrillation after stopping anti-hypertensive medication including beta-blockers and ACE inhibitors. Also, to assess the role of genetics in subsequent risk of stroke among patients with atrial fibrillation.

Detailed Description

BACKGROUND:

Prevention and treatment of atrial fibrillation (AF) is a significant public health issue. Atrial fibrillation affects 9 percent of persons aged 80 to 89. It is associated with elevated risk of stroke and death. The condition is likely to increase as survival rates from myocardial infarction continue to improve, prevalence of congestive heart failure grows, and treatment approaches evolve. The study will assess the safety of commonly used medications in relation to the risk of incident atrial fibrillation, and will assess the association of several genetic polymorphisms with stroke risk after AF onset. Several lines of evidence suggest that both beta-blockers and ACE inhibitors may prevent or inhibit the atrial electrical remodeling that allows AF to become established and maintained. Withdrawal of these medications may be associated with increased risk of AF in individuals at risk. Genetic polymorphisms that promote thrombosis are associated with an increased risk of venous thrombosis, and in some studies, with arterial thrombosis including stroke or myocardial infarction. Although several recently published trials indicate that warfarin or aspirin treatment of patients with AF decreases the risk of stroke, little is known about the risk of stroke as a complication of AF in relation to genetic variants that affect clotting.

DESIGN NARRATIVE:

The main tasks of the case-control study are: 1) identification of cases with incident AF and controls; 2) review of outpatient and inpatient medical records to assess eligibility and collect information on risk factors and medical history; 3) classification of medication use over time; 4) for AF patients, telephone interview and collection of blood samples; 5) blood specimen processing, DNA extraction, and genotyping; and 6) data analysis of the associations of medication use and genotype with AF onset and stroke complications.

Study Design

Study Type:
Observational
Study Start Date :
Jul 1, 2002
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Jun 1, 2008

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    No eligibility criteria

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • : Susan Heckbert, University of Washington

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00021905
    Other Study ID Numbers:
    • 974
    First Posted:
    Aug 10, 2001
    Last Update Posted:
    Jul 24, 2008
    Last Verified:
    Jul 1, 2008

    Study Results

    No Results Posted as of Jul 24, 2008