Autoimmunity & Coronary Artery Disease

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00106483
Study type	Observational
Source	Northwestern University
Contact
Status	Completed
Phase	N/A
Start date	February 2005
Completion date	January 2008

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Autoimmunity and Coronary Artery Disease - Ancillary to CARDIA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms