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Trial record 2 of 13 for:    Multi-Ethnic Study AND MESA

Multi-Ethnic Study of Atherosclerosis (MESA)

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.
 
ClinicalTrials.gov Identifier: NCT00005487
Recruitment Status : Active, not recruiting
First Posted : May 26, 2000
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date May 25, 2000
First Posted Date May 26, 2000
Last Update Posted Date November 7, 2019
Study Start Date January 1999
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 6, 2019)
CVD
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multi-Ethnic Study of Atherosclerosis (MESA)
Official Title Multi-Ethnic Study of Atherosclerosis (MESA)
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants were recruited from the MESA Study Field Centers.
Condition
  • Atherosclerosis
  • Cardiovascular Diseases
  • Heart Diseases
  • Coronary Artery Disease
  • Coronary Disease
  • Stroke
  • Myocardial Infarction
  • Heart Failure
  • Diabetes Mellitus, Type 2
  • Hypertension
  • Diabetes Mellitus
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: November 6, 2019)
6418
Original Enrollment Not Provided
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria CVD free men and women aged 45-84 at baseline from the four race/ethnic groups.
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00005487
Other Study ID Numbers 5003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Heart, Lung, and Blood Institute (NHLBI)
Study Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Collaborators Not Provided
Investigators
Principal Investigator: Robyn McClelland University of Washington
Principal Investigator: Russell Tracy University of Vermont (biospecimen repository)
Principal Investigator: Steven Shea Columbia University
Principal Investigator: Wendy Post Johns Hopkins University
Principal Investigator: Norrina Allen Northwestern University
Principal Investigator: Karol Watson University of California, Los Angeles
Principal Investigator: James Pankow University of Minnesota
Principal Investigator: Gregory Burke Wake Forest University
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date August 2019