Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106483
Status:
COMPLETED
Last Update Posted:
2015-03-19
First Post:
2005-03-24
Brief Title:
Autoimmunity and Coronary Artery Disease - Ancillary to CARDIA
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21HL079057 | NIH | None | httpsreporternihgovquickSearchR21HL079057 |