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Completed

NCT Number: NCT00063440

Epidemiology of Carotid IMT Progression in MESA - Ancillary Study

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Members of MESA study

Treatment and study plan

Primary outcomes

  1. Common carotid artery intima-media thickness

    Time frame: randomly selected at 2 years or 4 years in 1/2 of the cohort

Secondary outcomes

  1. Common carotid artery diameter

    Time frame: randomly selected at 2 or 4 years for each 1/2 of the cohort

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Jun 30, 2003
Registry last updated
Feb 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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