Aortic Calcium: Epidemiology and Progression -- Ancillary to MESA

Cardiovascular Diseases Clinical Trial

Official title:

Aortic Calcium: Epidemiology and Progression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00059124
• Other study ID #: 1213
• Secondary ID: R01HL072403
• Status: Completed
• Phase: N/A
• First received: April 17, 2003
• Last updated: July 10, 2013
• Start date: March 2003
• Est. completion date: February 2008

Study information

• Verified date: July 2013
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

To study the epidemiology of aortic calcium.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1980
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 84 Years
• Eligibility: Participation in the original MESA Study

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal Aortic Calcium		During the Exam 2 and Exam 3 MESA visits	No