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Autoimmunity and Coronary Artery Disease - Ancillary to CARDIA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00106483
Recruitment Status : Completed
First Posted : March 25, 2005
Last Update Posted : March 19, 2015
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Darcy Majka, Northwestern University

Brief 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.

Condition or disease
Cardiovascular Diseases Coronary Disease Heart Diseases

Detailed Description:


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.


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.

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Study Type : Observational
Actual Enrollment : 3020 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : February 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Coronary Artery Risk Development in Young Adults
There were no interventions.

Primary Outcome Measures :
  1. Coronary artery calcification (CAC) [ Time Frame: 8 years ]
    serum samples already collected by they CARDIA study in 1992 were tested by our ancillary study for autoantibodies and we analyzed whether autoantibody positivity was associated with CAC over 13 years of follow up in the CARDIA study. CAC was measured by the CARDIA study in 2000 and 2005.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All CARDIA participants with serum available in 1992 and coronary calcification measure in years 2000 and 2005.
No eligibility criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00106483

Sponsors and Collaborators
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Darcy Majka, MD MS Northwestern University School of Medicine

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Responsible Party: Darcy Majka, Assistant Professor in Medicine & Preventive Medicine, Northwestern University Identifier: NCT00106483     History of Changes
Other Study ID Numbers: 1291
R21HL079057 ( U.S. NIH Grant/Contract )
First Posted: March 25, 2005    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015
Keywords provided by Darcy Majka, Northwestern University:
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases
Arterial Occlusive Diseases