Epidemiology of Carotid IMT Progression in MESA - Ancillary Study
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Purpose
To determine the factors associated with progression of sub-clinical atherosclerosis and to evaluate the associations between the progression of sub-clinical atherosclerosis and the development of clinically manifest atherosclerosis.
| Condition |
|---|
|
Atherosclerosis Cardiovascular Diseases Heart Diseases Carotid Artery Diseases Coronary Arteriosclerosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
- Common carotid artery intima-media thickness [ Time Frame: randomly selected at 2 years or 4 years in 1/2 of the cohort ] [ Designated as safety issue: No ]
- Common carotid artery diameter [ Time Frame: randomly selected at 2 or 4 years for each 1/2 of the cohort ] [ Designated as safety issue: No ]
| Enrollment: | 5610 |
| Study Start Date: | June 2003 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
BACKGROUND:
Cardiovascular disease remains the leading cause of death in the United States and one of the leading causes of morbidity. New technology recently has allowed the non-invasive investigation of the extent of atherosclerosis in different vascular beds. Unfortunately, the clinical implications and significance of this new technology have not yet been fully examined nor has the interrelationship between these various measurements of clinical and sub-clinical atherosclerosis. The study is ancillary to the Multi-Ethnic Study of Atherosclerosis (MESA), an NHLBI-supported epidemiological study of atherosclerosis in several ethnic groups.
DESIGN NARRATIVE:
A longitudinal assessment of the carotid intima media thickness (IMT) will be added to the scheduled follow-up visits in MESA subjects in order to study the relationship between carotid IMT and a measure of calcium burden in the coronary vessels. In addition, studies will be conducted on how these two non-invasive markers of atherosclerosis relate to cardiovascular disease risk factors and clinical events.The study will utilize the MESA cohort involving 6500 subjects who will have baseline and four follow-up examinations. coronary artery calcification (CAC) and IMT are being obtained at baseline, with CAC determinations also scheduled at follow-up. IMT determinations will be added in conjunction with the CAC studies in the second and third exams and detailed analyses will be carried out on these two measures of atherosclerotic burden that may reflect different biologic processes.
Eligibility| Ages Eligible for Study: | 45 Years to 84 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Participants of the Multi-Ethnic Study of Atherosclerosis, a cross-sectional NIH population cohort originating from 6 regions in the United States
Members of MESA study
Contacts and Locations More Information
No publications provided by Tufts Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Tufts Medical Center |
| ClinicalTrials.gov Identifier: | NCT00063440 History of Changes |
| Other Study ID Numbers: | 1214, 5R01HL069003-05 |
| Study First Received: | June 26, 2003 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Arteriosclerosis Atherosclerosis Cardiovascular Diseases Carotid Artery Diseases Coronary Artery Disease Myocardial Ischemia Heart Diseases |
Arterial Occlusive Diseases Vascular Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Coronary Disease |
ClinicalTrials.gov processed this record on May 22, 2013