Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005487
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-27
First Post:
2000-05-25
Brief Title:
Multi-Ethnic Study of Atherosclerosis MESA
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
Multi-Ethnic Study of Atherosclerosis MESA
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 wwwmesa-nhlbiorg During 2000-2002 6814 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 wwwmesa-nhlbiorg The MESA data are available to qualifying investigators directly from the study and also through dbGaP httpwwwncbinlmnihgovgap and BioLINCC httpsbiolinccnhlbinihgov A variety of stored biospecimens are also available from the study including DNA serum plasma and urine
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 wwwmesa-nhlbiorg The MESA data are available to qualifying investigators directly from the study and also through dbGaP httpwwwncbinlmnihgovgap and BioLINCC httpsbiolinccnhlbinihgov A variety of stored biospecimens are also available from the study including DNA serum plasma and urine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None