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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 10, 2001 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | July 2002 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00021905 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Atrial Fibrillation Incidence, Risk Factors and Genetics | ||||
| Official Title ICMJE | |||||
| 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. |
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| 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. |
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| Study Phase | N/A | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | |||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | June 2008 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | No eligibility criteria |
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00021905 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 974 | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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