Clinical trial NCT00005487: Multi-Ethnic Study of Atherosclerosis (MESA)
Official title: Multi-Ethnic Study of Atherosclerosis (MESA)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atherosclerosis
Cardiovascular Diseases
Heart Diseases
Coronary Artery Disease
Coronary Disease
Stroke
Myocardial Infarction
Heart Failure
Diabetes Mellitus, Type 2
Hypertension
Diabetes Mellitus
Keywords: Coronary Arteriosclerosis
Cerebrovascular Accident
Heart Failure, Congestive
Diabetes Mellitus, Non-Insulin Dependent
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Enrollment: 6418
Sex: ALL
Minimum age (years): 45
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were recruited from the MESA Study Field Centers.

Brief summary: The Multi-Ethnic Study of Atherosclerosis (MESA) was initiated to study the correlates, predictors, and progression of subclinical cardiovascular disease (CVD) (disease detected non-invasively before it has produced clinical signs and symptoms) in a diverse population-based sample of men and women aged 45-84 who had no evidence of clinical CVD at baseline (www.mesa-nhlbi.org). During 2000-2002, 6,814 participants were recruited from six field centers (Forsyth County, NC; Northern Manhattan and the Bronx, NY; Baltimore City and Baltimore County, MD; St. Paul, MN; Chicago, IL; and Los Angeles County, CA). The ethnic composition of the recruited cohort was 38% Caucasian, 28% African American, 22% Hispanic, and 12% Chinese. An extensive baseline exam focused on critical CVD risk factors and subclinical disease measures. Five subsequent exams took place through 2018 to assess changes in these measures and to explore new innovative research questions. Cohort members are contacted annually to obtain information about intervening hospitalizations and outpatient cardiovascular-related procedures. Relevant medical records are abstracted and reviewed and clinical endpoints of interest are adjudicated. The study is comprised of one Coordinating Center, six Field Centers and one biospecimen repository.

Detailed description: Background:

MESA was derived from an NHLBI Task Force on Research in Epidemiology and Prevention in which investigation of subclinical disease and its progression to clinical disease was recommended as a major focus for future NHLBI population studies. This was followed by a Special Emphasis Panel on Longitudinal Cohort Studies in 1995, which strongly recommended studies based on subclinical disease measures, and the inclusion of underrepresented minorities in population-based research. A subsequent Special Emphasis Panel on Use of Cardiac EBCT and MRI in Epidemiologic Studies of Cardiovascular Disease in 1996 recommended inclusion of carotid and cardiac MRI and EBCT in elucidating the progression of subclinical to clinical disease and identifying subclinical disease characteristics most strongly associated with increased risk. Requests for Proposals were released in 1997 and awards were made in 1999.

Design Narrative:

Participants were examined at baseline for evidence of subclinical CVD using cardiac computed tomography (CT), cardiac MRI, carotid ultrasound, flow-mediated brachial artery dilation, radial artery tonometry, ankle-brachial index measurement; established and putative laboratory risk markers; and socioeconomic, psychological, behavioral, and environmental characteristics. Selected baseline components were repeated and additional components such as spirometry, retinal photography, genotyping, cognitive function assessment and, in subsets, abdominal aortic CT, carotid MRI, cardiac MRI tagging for measures of regional myocardial function, were introduced over five subsequent examinations through 2018. Stored blood samples have been assayed for putative biochemical risk factors and stored for case-control studies. DNA has been extracted for study of candidate genes, genome-wide scanning, expression, and other -omics investigations, and lymphocytes were cryopreserved for possible immortalization.

MESA is unique in its composition of four ethnic groups, having a cohort free of clinical CVD at baseline, and having multiple - and in some cases unique - subclinical CVD measures over time in the same individuals. Data collected from a large number and variety of MESA ancillary studies, including major ancillary studies on air pollution, chronic lung disease, genetics, and sleep, further contribute to its uniqueness. For a list of all phenotypic data documentation and protocols, refer to the MESA website: www.mesa-nhlbi.org. The MESA data are available to qualifying investigators directly from the study and also through dbGaP (http://www.ncbi.nlm.nih.gov/gap) and BioLINCC (https://biolincc.nhlbi.nih.gov). A variety of stored biospecimens are also available from the study, including DNA, serum, plasma, and urine.

Eligibility criteria: CVD free men and women aged 45-84 at baseline from the four race/ethnic groups.

Primary outcomes:
measure: CVD
timeFrame: 12/20/2023
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Robyn McClelland
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont (biospecimen repository)
name: Russell Tracy
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Steven Shea
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Wendy Post
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Norrina Allen
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Karol Watson
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: James Pankow
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University
name: Gregory Burke
role: PRINCIPAL_INVESTIGATOR
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