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
  Purpose

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.


Condition
Cardiovascular Diseases
Coronary Disease
Heart Diseases

Study Type: Observational

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: February 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00106483

Sponsors and Collaborators
Investigators
Investigator: Darcy Majka Northwestern University School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00106483     History of Changes
Other Study ID Numbers: 1291
Study First Received: March 24, 2005
Last Updated: April 22, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Coronary Disease
Heart Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014