- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00046605
Inflammation Genomics and Atherosclerosis - Ancillary to CARDIA
Study Overview
Status
Detailed Description
BACKGROUND:
Atherosclerosis is a major determinant of coronary heart disease and is determined by the interplay of genetic and environmental risk factors. Although atherosclerosis tends to aggregate in families, it does not exhibit classical Mendelian segregation. Thus, the genes that determine an individual's risk of atherosclerosis likely involve multiple sites within genes and interactions between genes, all of which define a genetic risk that is modified by the host environment.
DESIGN NARRATIVE:
The genetic epidemiology study examines the associations of common variation in inflammation/thrombosis genes with intermediate quantitative phenotypes and subclinical coronary atherosclerosis in the Coronary Artery Risk Factor Development in Young Adults (CARDIA) Study, a large, bi-racial cohort study. The set of 25 candidate genes involve pathways (cytokines, chemokines, and their receptors; cellular adhesion molecules; and, coagulation proteins) and include several receptor-ligand pairs. Using cladistic analysis and the resources of the Program in Genomic Applications (PGA), the investigators will identify a limited set of single nucleotide polymorphisms (range 3-10 SNPs per gene) that characterize common haplotypes in these candidate genes within persons of African descent and European descent. DNA from the CARDIA Year 10 examination (n = 3,950 subjects) will be genotyped for the selected variants that characterize the common haplotypes. Data on the presence of common variants and haplotypes will be incorporated into the CARDIA Study database. Levels of two important intermediate phenotypes, fibrinogen and C-reactive protein (CRP) were previously determined. Non-invasive assessment of coronary atherosclerosis, defined as the presence of coronary artery calcification (CAC), was obtained on CARDIA participants at the Year 15 exam. Analyses will be stratified by race/ethnicity and focus on the associations of the common haplotypes with fibrinogen, CRP, and CAC measured in early adult life. Secondarily, the investigators will explore possible gene-gene and gene-environment interactions. The proposed multi-disciplinary collaboration should enhance the sensitivity and specificity of efforts to assess the associations of common variation in sets of inflammation/thrombosis candidate genes and cardiovascular risk in young adults.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Siscovick, University of Washington
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21795
- R01HL071017-05 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Diseases
-
Baker Heart and Diabetes InstitutePrincess Alexandra Hospital, Brisbane, Australia; Royal Perth Hospital; Alice... and other collaboratorsRecruitingHeart Failure | Valve Heart DiseaseAustralia
-
Medical University of ViennaUnknownHeart Diseases | Heart Failure | Valvular Heart DiseaseAustria
-
Centre Chirurgical Marie LannelongueActive, not recruitingValvular Heart Disease | Valve Disease, Heart
-
Kathirvel SubramaniamUniversity of Maryland, Baltimore; CSL BehringRecruitingHeart Failure,Congestive | Heart Disease End StageUnited States
-
Nantes University HospitalDirectorate of Health Care SupplyNot yet recruitingHeart Diseases | Heart Failure | Heart Valve Diseases
-
Abiomed Inc.RecruitingHeart Diseases | Acute Decompensated Heart Failure | Congestive Heart Failure | Acute Heart FailureUnited States
-
University of MichiganTerminatedDiastolic Heart Failure | Hypertensive Heart DiseaseUnited States
-
Wuerzburg University HospitalRecruitingHeart Failure | Chronic Heart Failure | Chronic Heart DiseaseGermany
-
Yonsei UniversityCompletedMitral Valvular Heart Disease
-
Aristotle University Of ThessalonikiRecruitingCardiovascular Diseases | Heart Failure | Valvular Heart Disease | Biochemical DysfunctionGreece