Clincosm LogoSign in Get a demo

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

Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00065780
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
6,814
Enrollment
59
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 :
    Aug 1, 2003
    Actual Primary Completion Date :
    Jul 1, 2008
    Actual Study Completion Date :
    Jul 1, 2008

    Outcome Measures

    Primary Outcome Measures

    1. Valve Calcification [2002, again in 2004-5]

      valve calcification of aortic and mitral valve

    2. Aortic valve calcification [2002, again in 2004-2005]

      valve calcification of the aortic valve on cardiac ct

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 84 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    No eligibility criteria

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Matthew J. Budoff, Principal investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    ClinicalTrials.gov Identifier:
    NCT00065780
    Other Study ID Numbers:
    • 1231
    • R01HL071739
    First Posted:
    Aug 4, 2003
    Last Update Posted:
    Oct 28, 2013
    Last Verified:
    Oct 1, 2013
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Heart Diseases
    Atherosclerosis
    Arteriosclerosis
    Coronary Artery Disease
    Myocardial Ischemia

    Study Results

    No Results Posted as of Oct 28, 2013