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

June 26, 2003
February 6, 2013
June 2003
May 2008   (final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT00063440 on ClinicalTrials.gov Archive Site
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 ]
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Epidemiology of Carotid IMT Progression in MESA - Ancillary Study
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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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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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

  • Atherosclerosis
  • Cardiovascular Diseases
  • Heart Diseases
  • Carotid Artery Diseases
  • Coronary Arteriosclerosis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5610
May 2008
May 2008   (final data collection date for primary outcome measure)

Members of MESA study

Both
45 Years to 84 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00063440
1214, 5R01HL069003-05
Not Provided
Tufts Medical Center
Tufts Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Joseph F Polak, MD, MPH Tufts Medical Center
Tufts Medical Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP