We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Atherosclerosis, Plaque and CVD in Communities

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00091754
First Posted: September 20, 2004
Last Update Posted: July 24, 2008
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.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00091754


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Eric Boerwinkle University of Texas
  More Information

ClinicalTrials.gov Identifier: NCT00091754     History of Changes
Other Study ID Numbers: 1269
First Submitted: September 16, 2004
First Posted: September 20, 2004
Last Update Posted: July 24, 2008
Last Verified: July 2008

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