Epidemiology of Carotid IMT Progression in MESA - Ancillary Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00063440
First received: June 26, 2003
Last updated: February 6, 2013
Last verified: February 2013
  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

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   45 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants of the Multi-Ethnic Study of Atherosclerosis, a cross-sectional NIH population cohort originating from 6 regions in the United States

Criteria

Members of MESA study

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00063440

Sponsors and Collaborators
Tufts Medical Center
Investigators
Principal Investigator: Joseph F Polak, MD, MPH Tufts Medical Center
  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:
Cardiovascular Diseases
Heart Diseases
Atherosclerosis
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Carotid Artery Diseases
Arterial Occlusive Diseases
Vascular Diseases
Coronary Disease
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014