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Atrial Fibrillation Incidence, Risk Factors and Genetics
This study has been completed.
Study NCT00021905   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: August 10, 2001   Last Updated: July 23, 2008   History of Changes

August 10, 2001
July 23, 2008
July 2002
June 2008   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00021905 on ClinicalTrials.gov Archive Site
 
 
 
Atrial Fibrillation Incidence, Risk Factors and Genetics
 

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.

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.

N/A
Observational
 
  • Atrial Fibrillation
  • Cardiovascular Diseases
  • Heart Diseases
  • Hypertension
  • Cerebrovascular Accident
  • Arrhythmia
 
 
Glazer NL, Smith NL, Heckbert SR, Doggen CJ, Lemaitre RN, Psaty BM. Risk of myocardial infarction attributable to elevated levels of total cholesterol among hypertensives. Am J Hypertens. 2005 Jun;18(6):759-66.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
June 2008
June 2008   (final data collection date for primary outcome measure)

No eligibility criteria

Both
 
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00021905
 
974
National Heart, Lung, and Blood Institute (NHLBI)
 
Investigator: Susan Heckbert University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP