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

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ClinicalTrials.gov Identifier: NCT00065780
Recruitment Status : Completed
First Posted : August 4, 2003
Last Update Posted : October 28, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To rescan 6,700 subjects in the MESA study to obtain computed tomography measures of calcification.

Condition or disease
Cardiovascular Diseases Heart Diseases Atherosclerosis Coronary Arteriosclerosis

Detailed 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.


Study Design

Study Type : Observational
Actual Enrollment : 6814 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : August 2003
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Valve Calcification [ Time Frame: 2002, again in 2004-5 ]
    valve calcification of aortic and mitral valve

  2. Aortic valve calcification [ Time Frame: 2002, again in 2004-2005 ]
    valve calcification of the aortic valve on cardiac ct


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
MESA study population - 6814 participants from 6 clinic sites around the US
Criteria
No eligibility criteria
More Information

Responsible Party: Matthew J. Budoff, Principal investigator, Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT00065780     History of Changes
Other Study ID Numbers: 1231
R01HL071739 ( U.S. NIH Grant/Contract )
First Posted: August 4, 2003    Key Record Dates
Last Update Posted: October 28, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Atherosclerosis
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Coronary Disease