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
  Purpose

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


Condition
Cardiovascular Diseases
Heart Diseases
Atherosclerosis
Coronary Arteriosclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Los Angeles Biomedical Research Institute:

Primary Outcome Measures:
  • 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


Enrollment: 6814
Study Start Date: August 2003
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   45 Years to 84 Years
Genders Eligible for Study:   Both
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: July 31, 2003
Last Updated: October 25, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 31, 2014