Autoimmunity and Coronary Artery Disease - Ancillary to CARDIA

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00106483
First received: March 24, 2005
Last updated: April 22, 2008
Last verified: April 2008

March 24, 2005
April 22, 2008
February 2005
January 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00106483 on ClinicalTrials.gov Archive Site
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Autoimmunity and Coronary Artery Disease - Ancillary to CARDIA
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To test the primary hypothesis that individuals with pre-clinical connective tissue disease related autoimmunity are more likely to demonstrate subsequent development of sub-clinical coronary artery disease.

BACKGROUND:

Connective tissue diseases have been identified as risk factors for coronary artery disease (CAD). Patients with connective tissue diseases such as rheumatoid arthritis and systemic lupus erythematosus have a high prevalence of CAD and are younger than expected at the onset of CAD. It has been proposed that the association between these connective tissue diseases and CAD is related to inflammation. Furthermore, circulating autoantibodies have been identified in CAD and it has been hypothesized that CAD may have autoimmune features. Circulating autoantibodies exist prior to connective tissue disease development and the presence of such autoantibodies in asymptomatic individuals is a predictor of future clinical connective tissue disease. Although the association between connective tissue disease and CAD has been established, an association between pre-clinical circulating autoantibodies and early CAD has not yet been explored.

DESIGN NARRATIVE:

To test this hypothesis, the following specific aims are proposed using the CARDIA database: 1) Determine the association between autoimmunity measured in stored sera collected in 1992 and the subsequent development of sub-clinical CAD measured in 2000 and 2005. 2) Assess whether autoimmunity measured in 1992 predicts future increased levels of C-reactive protein (CRP) and whether the relationship between autoimmunity and CAD is mediated by CRP level. These aims will be accomplished by a team of investigators within the Division of Rheumatology and Department of Preventive Medicine at Northwestern University. The CARDIA database is a product of the Coronary Artery Risk Development in Young Adults (CARDIA) study, a prospective cohort of 5108 subjects followed since 1985 for development of novel cardiac risk factors. With its extensive epidemiologic database and stored serum collected serially and available from 3500 individuals over the past 20 years, the CARDIA study is an ideal resource for this study.

Observational
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  • Cardiovascular Diseases
  • Coronary Disease
  • Heart Diseases
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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January 2008
January 2008   (final data collection date for primary outcome measure)

No eligibility criteria

Male
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00106483
1291
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Darcy Majka Northwestern University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
April 2008

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