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Atherosclerosis, Plaque and CVD in Communities

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ClinicalTrials.gov Identifier: NCT00091754
Recruitment Status : Completed
First Posted : September 20, 2004
Last Update Posted : July 24, 2008
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date September 16, 2004
First Posted Date September 20, 2004
Last Update Posted Date July 24, 2008
Study Start Date September 2004
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00091754 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Atherosclerosis, Plaque and CVD in Communities
Official Title Not Provided
Brief Summary To identify new cellular, metabolic, and genomic correlates of atherosclerotic plaque and early pathologic changes in the vascular wall and determine their consequences for coronary heart disease and stroke.
Detailed Description

BACKGROUND:

This study draws upon the existing ARIC cohort of 15,792 members aged 45-64 years at baseline in 1987-1989 who have completed four clinic exams three years apart with the last exam in 1998. The longitudinal ARIC cohort study focused on new cardiovascular disease [CVD] risk factors and subclinical measures of atherosclerosis through B-mode ultrasound of the carotid arteries. The current study collects new and novel risk factors and performs carotid magnetic resonance imaging (MRI) examinations on a stratified random sample of 1,200 ARIC participants with high (>85th percentile) carotid intimal-medial thickness [IMT] by ultrasound and 800 participants with <85th percentile IMT.

DESIGN NARRATIVE:

The study examines an informative subset of the bi-ethnic Atherosclerosis Risk in Communities (ARIC) cohort to identify cellular, metabolic and genomic correlates of atherosclerotic plaque characteristics and of early changes in the vascular wall. The longitudinal follow-up and stored DNA in ARIC will allow testing the ability of the genomic correlates of plaque characteristics to predict incident coronary heart disease and stroke. One thousand two hundred individuals with high (>85th percentile) carotid artery wall thickness documented by B-mode ultrasound and 800 individuals sampled from the remainder of the carotid artery wall thickness distribution (<85th percentile) will receive a contrast-enhanced carotid MRI examination. Standardized MRI measures will include carotid artery wall thickness, T2 signal intensity changes and percent contrast enhancement indicative of endothelial dysfunction, and for those with plaque, fibrous cap thickness, lipid core volume, and calcification. Novel cellular, metabolic and genomic measures will be collected and will be related to MRI-measurable plaque characteristics. In particular, flow cytometry will be used to measure monocyte and platelet presentation of cytokines, growth factors and adhesion molecules, and cell-cell aggregation. High throughput genotyping methods will be used to measure 5 to 7 polymorphic sites in each of 150 positional, expressional and biologic candidate genes, permitting multilocus and haplotype genomic analyses. The depth and breadth of existing risk factor and lifestyle data, extensive follow-up since 1986-89, and accumulation of clinical outcomes, including coronary heart disease, stroke and arteriosclerosis, contribute additional strengths to the laboratory and MRI investigations. Inferences will be made both cross-sectionally and longitudinally, with a special emphasis on genotype plus environment interaction. The ARIC cohort is in an ideal age range for the research because of the frequent and documented occurrence of plaque and the spectrum of clinically relevant stages from plaque initiation to mature fibrosis, calcification and even erosion and near-rupture.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Atherosclerosis
  • Cardiovascular Diseases
  • Heart Diseases
  • Cerebrovascular Accident
  • Coronary Arteriosclerosis
  • Coronary Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment Not Provided
Original Enrollment Not Provided
Actual Study Completion Date June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria No eligibility criteria
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00091754
Other Study ID Numbers 1269
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Collaborators Not Provided
Investigators
Investigator: Eric Boerwinkle University of Texas
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date July 2008