Epidemiology of Vascular Inflammation & Atherosclerosis

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:

BACKGROUND:

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.

DESIGN NARRATIVE:

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 Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	45 Years to 84 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

1,000 men and women aged 45-84 years

Criteria

No eligibility criteria

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

University of Vermont

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:	Russell Tracy	University of Vermont

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Additional relevant MeSH terms:

Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Coronary Disease; Coronary Artery Disease; Stroke; Arteriosclerosis; Myocardial Ischemia	Intracranial Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases