Epidemiology of Carotid IMT Progression in MESA - Ancillary Study

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00063440
• Other study ID #: 1214
• Secondary ID: 5R01HL069003-05
• Status: Completed
• Phase: N/A
• First received: June 26, 2003
• Last updated: February 6, 2013
• Start date: June 2003
• Est. completion date: May 2008

Study information

• Verified date: February 2013
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5610
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 84 Years
• Eligibility: Members of MESA study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arteriosclerosis
• Atherosclerosis
• Cardiovascular Diseases
• Carotid Artery Diseases
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Common carotid artery intima-media thickness		randomly selected at 2 years or 4 years in 1/2 of the cohort	No
Secondary	Common carotid artery diameter		randomly selected at 2 or 4 years for each 1/2 of the cohort	No