Ventricular Size and Value Calcification Measures by Computed Tomography - Ancillary to MESA

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00065780
• Other study ID #: 1231
• Secondary ID: R01HL071739
• Status: Completed
• Phase: N/A
• First received: July 31, 2003
• Last updated: October 25, 2013
• Start date: August 2003
• Est. completion date: July 2008

Study information

• Verified date: October 2013
• Source: Los Angeles Biomedical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

To rescan 6,700 subjects in the MESA study to obtain computed tomography measures of calcification.

Description:

BACKGROUND:

This study is ancillary to the MultiEthnic Study of Atherosclerosis (MESA) Trial, a prospective investigation of the etiology and natural history of atherosclerosis and the ability of non-invasive tools to measure atherosclerotic burden and identify high risk individuals in a large, population-based cohort. The development of computed tomography (CT) to evaluate coronary calcification (CC) now provides a tool to directly measure coronary atherosclerosis non-invasively. The information obtained by CT however provides more information than CC alone. CT has the ability to measure and quantitate aortic valve calcification (AVC), mitral annular calcification (MAC), aortic wall calcification and left ventricular size (LVS). The longitudinal nature of this study will allow epidemiologic associations to be established for a multitude of risk factors and these measures, establishing both the time sequence for each measure and consistency of the association in a variety of populations (ethnicity, gender, geographical location and age). Magnetic resonance imaging of the heart will also be obtained as part of the MESA trial, and comparisons of LV size by CT to magnetic resonance measures will also be performed.

DESIGN NARRATIVE:

This study is ancillary to the MultiEthnic Study of Atherosclerosis (MESA) Trial, a prospective investigation of the etiology and natural history of atherosclerosis and the ability of non-invasive tools to measure atherosclerotic burden and identify high risk individuals in a large, population-based cohort. The development of computed tomography (CT) to evaluate coronary calcification (CC) now provides a tool to directly measure coronary atherosclerosis non-invasively. The information obtained by CT however provides more information than CC alone. CT has the ability to measure and quantitate aortic valve calcification (AVC), mitral annular calcification (MAC), aortic wall calcification and left ventricular size (LVS). The longitudinal nature of this study will allow epidemiologic associations to be established for a multitude of risk factors and these measures, establishing both the time sequence for each measure and consistency of the association in a variety of populations (ethnicity, gender, geographical location and age). Magnetic resonance imaging of the heart will also be obtained as part of the MESA trial, and comparisons of LV size by CT to magnetic resonance measures will also be performed. The investigators will utilize scans already obtained as part of the calcium scanning (at baseline and 3.5 year follow-up), and make these four measures on baseline and follow-up scans obtained. The additive value of these simple measures to CC score could possibly provide clinicians with even more power to identify and stratify the high-risk cardiac patient with both findings. This study will also establish the prevalence, in a population based study, of all both AVC and MAC, using a technique highly sensitive to see these abnormalities. It has been postulated that a 'total atherosclerotic burden' could be obtained by adding CAC to thoracic aortic calcification, and this total atherosclerosis score (with or without MAC and AVC) might better predict cardiovascular events than CAC alone. Similarly, this cohort of 6,700 patients with repeat scans can be assessed for factors that enhance or inhibit progression of LVS, mitral annular, aortic valve or wall calcification, lending insight into therapies that have efficacy against progression of aortic sclerosis or left ventricular enlargement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6814
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 84 Years
• Eligibility: No eligibility criteria

Study Design

Observational Model: Cohort, 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
Los Angeles Biomedical Research Institute	National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Valve Calcification	valve calcification of aortic and mitral valve	2002, again in 2004-5	No
Primary	Aortic valve calcification	valve calcification of the aortic valve on cardiac ct	2002, again in 2004-2005	No