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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Matthew J. Budoff, Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT00065780
First received: July 31, 2003
Last updated: October 25, 2013
Last verified: October 2013

July 31, 2003
October 25, 2013
August 2003
July 2008   (final data collection date for primary outcome measure)
  • Valve Calcification [ Time Frame: 2002, again in 2004-5 ] [ Designated as safety issue: No ]
    valve calcification of aortic and mitral valve
  • Aortic valve calcification [ Time Frame: 2002, again in 2004-2005 ] [ Designated as safety issue: No ]
    valve calcification of the aortic valve on cardiac ct
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Complete list of historical versions of study NCT00065780 on ClinicalTrials.gov Archive Site
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Ventricular Size and Value Calcification Measures by Computed Tomography - Ancillary to MESA
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To rescan 6,700 subjects in the MESA study to obtain computed tomography measures of calcification.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

MESA study population - 6814 participants from 6 clinic sites around the US

  • Cardiovascular Diseases
  • Heart Diseases
  • Atherosclerosis
  • Coronary Arteriosclerosis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6814
July 2008
July 2008   (final data collection date for primary outcome measure)

No eligibility criteria

Both
45 Years to 84 Years
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00065780
1231, R01HL071739
Not Provided
Matthew J. Budoff, Los Angeles Biomedical Research Institute
Los Angeles Biomedical Research Institute
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
Los Angeles Biomedical Research Institute
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP