Epidemiology of Vascular Inflammation & Atherosclerosis

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. Identifier: NCT00087893
Recruitment Status : Completed
First Posted : July 19, 2004
Last Update Posted : September 27, 2013
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Russell Tracy, University of Vermont

Brief Summary:
To investigate the relationship of vascular cell phenotypes to atherosclerosis.

Condition or disease
Atherosclerosis Cardiovascular Diseases Heart Diseases Coronary Arteriosclerosis Coronary Disease Cerebral Arteriosclerosis Cerebrovascular Accident

Detailed Description:


Currently, the predominant hypothesis regarding atherosclerosis is that it is in major part driven by two independent pathways: hyperlipidemia (the "stimulation") and inflammation (the "response"). Although vascular cells mediate the influence of inflammation on atherosclerosis, very little is known about vascular cell epidemiology and the relationship of vascular cell phenotypes to atherosclerosis. The main hypothesis tested in this study is that variation in vascular cell biology is related to the population variation in atherosclerosis.


The cross-sectional study will be nested within a large cohort study, the Multiethnic Study of Atherosclerosis (MESA). A partial sample of 1,000 individuals who have undergone other special laboratory analyses will be identified and new measures collected as part of their upcoming site visit. A number of novel cellular phenotypes describing the innate immune response (monocyte activation, natural killer and T cell counts), the adaptive immune response (TH1 and TH2 helper cells, and memory T cells), and vessel integrity (circulating endothelial progenitor cells) will be measured in these participants. Plasma constituents will also be measured that relate to the cellular phenotypes. The overall goal is to test the hypothesis that these novel phenotypes are associated with subclinical atherosclerosis in the coronary and carotid arteries assessed by quantification of coronary calcification (CAC) and B-mode ultrasound (CIMT), in addition to the other subclinical measures available from the MESA cohort.

Study Type : Observational
Actual Enrollment : 931 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Study Start Date : July 2004
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Primary Outcome Measures :
  1. T helper bias [ Time Frame: 2008 ]
    T helper bias is a stable phenotype in people, with few environmental drives; the main environmental driver appears to be anti-CMV titer; this has led to our view that genetics probably plays a role, and our current GWAS efforts using our unique MESA-Inflammation cellular phenotypes.

Secondary Outcome Measures :
  1. T helper bias toward Th1 cells [ Time Frame: 2008 ]
    T helper bias towards Th1 cells is strongly associated with measures of atherosclerosis in the population-based study MESA-Inflammation (both coronary calcification and carotid wall thickness) after fully adjusting for traditional and novel CVD risk factors. This is consistent with our original hypothesis, based on small human studies and mouse data.

Other Outcome Measures:
  1. atherosclerosis [ Time Frame: 2008 ]
    Both IL-10 and sIL-2R are also associated with atherosclerosis in humans as we hypothesized.

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
1,000 men and women aged 45-84 years
No eligibility criteria

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 identifier (NCT number): NCT00087893

Sponsors and Collaborators
University of Vermont
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Russell Tracy University of Vermont

Responsible Party: Russell Tracy, Professor of Pathology, University of Vermont Identifier: NCT00087893     History of Changes
Other Study ID Numbers: 1261
R01HL077449 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2004    Key Record Dates
Last Update Posted: September 27, 2013
Last Verified: September 2013

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