Atherosclerosis, Plaque and CVD in Communities

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00091754
First received: September 16, 2004
Last updated: July 23, 2008
Last verified: July 2008
  Purpose

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.


Condition
Atherosclerosis
Cardiovascular Diseases
Heart Diseases
Cerebrovascular Accident
Coronary Arteriosclerosis
Coronary Disease

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 2004
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00091754

Sponsors and Collaborators
Investigators
Investigator: Eric Boerwinkle University of Texas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00091754     History of Changes
Other Study ID Numbers: 1269
Study First Received: September 16, 2004
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Cerebral Infarction
Brain Infarction
Brain Ischemia
Brain Diseases
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Stroke
Myocardial Ischemia
Vascular Diseases
Arterial Occlusive Diseases
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014