Epidemiology of Carotid IMT Progression in MESA - Ancillary Study

Completed

• Conditions: Atherosclerosis; Cardiovascular Diseases; Heart Diseases; Carotid Artery Diseases; Coronary Arteriosclerosis

• Registration Number: NCT00063440
• Lead Sponsor: Tufts Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2003-06-26
• Study First Submitted QC: 2003-06-27
• Study First Posted: 2003-06-30
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-06
• Last Update Posted: 2013-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5610

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Common carotid artery intima-media thickness	randomly selected at 2 years or 4 years in 1/2 of the cohort

Secondary Outcome Measures

Name	Time	Method
Common carotid artery diameter	randomly selected at 2 or 4 years for each 1/2 of the cohort