Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00005487 |
| Other study ID # |
5003 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1999 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
December 2023 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
