- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00059124
Aortic Calcium: Epidemiology and Progression -- Ancillary to MESA
Aortic Calcium: Epidemiology and Progression
Study Overview
Status
Detailed Description
BACKGROUND:
Aortic calcium measured by computed tomography occurs earlier in life than other subclinical (that is, asymptomatic) markers of cardiovascular disease (CVD), shows a wide range, and is common in women. The large size of the aorta and relative lack of image artifact from motion make it ideal for radiographic quantitative imaging. This study is ancillary to and coordinated with the Multi-Ethnic Study of Atherosclerosis (MESA), a large prospective epidemiologic study investigating multiple subclinical CVD measures and CVD risk factors. Subclinical measures in MESA include coronary calcium, carotid ultrasound, cardiac magnetic resonance imaging, and the ankle/brachial blood pressure index. The extensive CVD risk factor measurements include both traditional risk factors and newer measures such as inflammatory and genetic markers.
DESIGN NARRATIVE:
This ancillary study will determine the epidemiology of aortic calcium in 2000 randomly selected (from 6500 total) MESA participants. Questions to be addressed include predictors of aortic calcium progression; associations of aortic calcium and aortic calcium progression with other subclinical CVD measures, CVD risk factors, and demographics; and the prognostic significance of aortic calcium. The project has three primary specific aims: 1) to predict the cross-sectional aortic calcium burden as a function of other subclinical CVD measures and CVD risk factors; 2) to predict aortic calcium progression as a function of other subclinical CVD measures and CVD risk factors, and 3) to predict aortic calcium progression as a function of progression of selected subclinical CVD measures and CVD risk factors. The two secondary specific aims are 1) to contrast the results of the three primary specific aims for men vs. women, and for four major ethnic groups (White, Hispanic, Black, and Asian); and 2) to provide a database for future evaluation of whether aortic calcium and/or aortic calcium progression independently predict subsequent myocardial infarction, stroke, and other CVD events.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Abdominal Aortic Calcium
Time Frame: During the Exam 2 and Exam 3 MESA visits
|
During the Exam 2 and Exam 3 MESA visits
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michael H Criqui, MD, MPH, University of California, San Diego
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1213
- R01HL072403 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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