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Long-Term Effects of Subclinical CAD on Cardiac Function

Primary Purpose

Cardiovascular Diseases, Coronary Arteriosclerosis, Coronary Disease

Status
Withdrawn
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

48 Years - 98 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 16, 2000
    Last Updated
    January 27, 2021
    Sponsor
    University of California, Irvine
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00006497
    Brief Title
    Long-Term Effects of Subclinical CAD on Cardiac Function
    Official Title
    Long-Term Effects of Subclinical CAD on Cardiac Function
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Nonapplicable clinical trial
    Study Start Date
    September 2000 (undefined)
    Primary Completion Date
    August 2008 (Actual)
    Study Completion Date
    August 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, Irvine
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To assess changes in coronary calcium measured by electron beam computed tomography (EBCT) as a predictor of coronary heart disease (CHD) events.
    Detailed Description
    BACKGROUND: Despite extensive research over many years, noninvasive methods for detection of the presence and severity of coronary artery disease remain imperfect, in part due to the fact that different, partially interrelated, facets of coronary atherosclerosis may predispose to different manifestations (e.g., luminal diameter narrowing to myocardial ischemia and wall plaque burden to a higher risk or acute thrombosis). One noninvasive index of the degree of coronary atherosclerosis, the extent of coronary artery calcification, has become more accessible to non-invasive evaluation due to the development of fast electron-beam computed tomography (EBCT). Initial studies have shown that EBCT coronary calcification is related to a variety of coronary risk factors and is also predictive to a variable extent in different populations of incident coronary heart disease events, but few data are available concerning the evolution of EBCT-detected coronary calcification and its relation to coronary risk factors or to prevalent or incident coronary heart disease. The study draws on the success of the Los Angeles South Bay Heart Watch (SBHW) in recruiting an ethnically-diverse sample of individuals at high risk of coronary heart disease events who have undergone serial evaluation by both assessment of conventional coronary heart disease risk factors and by evaluation of coronary arterial calcification by fluoroscopy and by EBCT on sequential evaluations. The study group has been able to maintain contact with the participants and achieve outstanding rates of both contact for follow-up and repeat participation in sequential components of the study. DESIGN NARRATIVE: The study follows up 1,000 asymptomatic high-risk survivors from the South Bay Heart Watch population recruited in 1990-1992 (n = 1,461) and studied with EBCT in 1992-1993 (n = 1,309). The primary objective is to examine the effects of baseline risk factors and measures of calcium metabolism on changes in the amount of coronary calcium in this asymptomatic high-risk adult cohort. This observational study has the following specific aims, as follow: 1) relating demographic factors and traditional risk factors to progression in coronary artery calcification (CAC) score over time; 2) relating serum markers of calcium metabolism to changes in CAC score; and 3) relating baseline CAC score and changes in CAC score to left ventricular dysfunction and intervening coronary events. The SBHW cohort and NHLBI reading center as well as Dr. Azen's data coordinating center are used to examine whether baseline risk factors, ethnic group and indices of calcium metabolism are associated with change in coronary calcium quantity over four to five years. EBCT scans are performed in 1,000 surviving members of the cohort as are repeat measurements of left ventricular hypertrophy, plasma lipids, blood pressure, homocysteine, fibrinogen, para-thyroid hormone and vitamin D levels. The independent relationships between risk factors are examined from the 1994 baseline evaluation and the change in coronary calcium score as determined by EBCT. Logistic regression, which is not dependent on normality of the independent variables, will be used to examine the relation of annualized change in coronary calcium with the incidence of events. The study continues through August, 2008.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Coronary Arteriosclerosis, Coronary Disease, Heart Diseases

    7. Study Design

    Enrollment
    0 (Actual)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    48 Years
    Maximum Age & Unit of Time
    98 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert Detrano
    Organizational Affiliation
    Harbor-UCLA Research & Education Institute

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12379576
    Citation
    Park R, Detrano R, Xiang M, Fu P, Ibrahim Y, LaBree L, Azen S. Combined use of computed tomography coronary calcium scores and C-reactive protein levels in predicting cardiovascular events in nondiabetic individuals. Circulation. 2002 Oct 15;106(16):2073-7. doi: 10.1161/01.cir.0000033819.29662.09.
    Results Reference
    background
    PubMed Identifier
    14722147
    Citation
    Greenland P, LaBree L, Azen SP, Doherty TM, Detrano RC. Coronary artery calcium score combined with Framingham score for risk prediction in asymptomatic individuals. JAMA. 2004 Jan 14;291(2):210-5. doi: 10.1001/jama.291.2.210. Erratum In: JAMA. 2004 Feb 4;291(5):563.
    Results Reference
    background

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    Long-Term Effects of Subclinical CAD on Cardiac Function

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