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Coronary Artery Calcium, Exercise Tests, and CHD Outcome

Primary Purpose

Cardiovascular Diseases, Coronary Disease, Cerebrovascular Disorders

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
The Cooper Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - undefined (Child, 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
    May 25, 2000
    Last Updated
    March 12, 2014
    Sponsor
    The Cooper Institute
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005562
    Brief Title
    Coronary Artery Calcium, Exercise Tests, and CHD Outcome
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1999 (undefined)
    Primary Completion Date
    August 2006 (Actual)
    Study Completion Date
    August 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    The Cooper Institute
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To investigate coronary artery calcium (CAC), detected by electron beam computed tomography (EBCT), as a predictor of coronary heart disease (CHD) mortality and morbidity, stroke, and all-cause mortality in a historical cohort epidemiological study.
    Detailed Description
    BACKGROUND: Dramatic advances in medical and interventional treatment of clinically overt CHD have contributed substantially, perhaps predominately, to the decline over the past three decades in CHD mortality that has occurred despite relatively unchanged rates of myocardial infarction. By analogy, it is attractive to assume that substantial benefit could also be given to individuals with significant but asymptomatic coronary artery disease if only they could be accurately diagnosed. In this context, research to determine whether or not a non-invasive method like EBCT has sufficient independent predictive value for CHD events to play a useful role in this process has potentially considerable clinical and public health importance. DESIGN NARRATIVE: Follow-up of the 5,400 women and 12,600 men will be for an average of about 2.75 years with approximately 15,000 woman-years and 35,000 man-years of observations being available for analyses by June 30, 2000. An important strength of the study is the self-reported key health variables at baseline for all study participants. In addition, objective measures of blood pressure, total cholesterol, HDL- cholesterol, triglyceride, plasma glucose, resting and exercise electrocardiograms (ECG), maximal health rates, cardiorespiratory fitness, and other clinical and biochemical measurements are available for about half of the participants. CAC by EBCT has been associated with prevalent CHD and with incident CHD in recent small prospective studies. However, it is unclear whether CAC is predictive of MI or CHD deaths, because currently available studies had few individuals with evidence of hard CVD endpoints. The large cohort with CAC measurements provides the power to investigate an association between CAC and CHD morbidity, stroke, and all- cause mortality in terms of thresholds or dose-response effects. Exercise test results and measures of conventional CHD risk factors, including several health behaviors and biochemical markers, are available for about 50 percent of the participants. This will allow evaluation of the separate and independent predictive value of CAC and exercise test results and the combination of these two exposures in relation to study outcomes. Furthermore, CAC scores, exercise test results, and the presence of conventional risk factors will be used together to identify participants at the highest risk of developing CHD outcomes.

    6. Conditions and Keywords

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

    7. Study Design

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Lamonte
    Organizational Affiliation
    Cooper Institute for Aerobics Research

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    10984822
    Citation
    Wei M, Schwertner HA, Blair SN. The association between physical activity, physical fitness, and type 2 diabetes mellitus. Compr Ther. 2000 Fall;26(3):176-82. doi: 10.1007/s12019-000-0006-9.
    Results Reference
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    PubMed Identifier
    10857962
    Citation
    Wei M, Gibbons LW, Mitchell TL, Kampert JB, Blair SN. Alcohol intake and incidence of type 2 diabetes in men. Diabetes Care. 2000 Jan;23(1):18-22. doi: 10.2337/diacare.23.1.18.
    Results Reference
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    PubMed Identifier
    10766678
    Citation
    Wei M, Gibbons LW, Kampert JB, Nichaman MZ, Blair SN. Low cardiorespiratory fitness and physical inactivity as predictors of mortality in men with type 2 diabetes. Ann Intern Med. 2000 Apr 18;132(8):605-11. doi: 10.7326/0003-4819-132-8-200004180-00002.
    Results Reference
    background
    PubMed Identifier
    11838643
    Citation
    Blair SN, Nichaman MZ. The public health problem of increasing prevalence rates of obesity and what should be done about it. Mayo Clin Proc. 2002 Feb;77(2):109-13. doi: 10.4065/77.2.109. No abstract available.
    Results Reference
    background
    PubMed Identifier
    12554597
    Citation
    Nguyen-Duy TB, Nichaman MZ, Church TS, Blair SN, Ross R. Visceral fat and liver fat are independent predictors of metabolic risk factors in men. Am J Physiol Endocrinol Metab. 2003 Jun;284(6):E1065-71. doi: 10.1152/ajpendo.00442.2002. Epub 2003 Jan 28.
    Results Reference
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    PubMed Identifier
    12943866
    Citation
    Cheng YJ, Church TS, Kimball TE, Nichaman MZ, Levine BD, McGuire DK, Blair SN. Comparison of coronary artery calcium detected by electron beam tomography in patients with to those without symptomatic coronary heart disease. Am J Cardiol. 2003 Sep 1;92(5):498-503. doi: 10.1016/s0002-9149(03)00714-8.
    Results Reference
    background
    PubMed Identifier
    15113739
    Citation
    Blair SN, LaMonte MJ, Nichaman MZ. The evolution of physical activity recommendations: how much is enough? Am J Clin Nutr. 2004 May;79(5):913S-920S. doi: 10.1093/ajcn/79.5.913S.
    Results Reference
    background
    PubMed Identifier
    14767252
    Citation
    Wong SL, Katzmarzyk P, Nichaman MZ, Church TS, Blair SN, Ross R. Cardiorespiratory fitness is associated with lower abdominal fat independent of body mass index. Med Sci Sports Exerc. 2004 Feb;36(2):286-91. doi: 10.1249/01.MSS.0000113665.40775.35.
    Results Reference
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    PubMed Identifier
    15281020
    Citation
    Kuk JL, Nichaman MZ, Church TS, Blair SN, Ross R. Liver fat is not a marker of metabolic risk in lean premenopausal women. Metabolism. 2004 Aug;53(8):1066-71. doi: 10.1016/j.metabol.2004.02.016.
    Results Reference
    background
    PubMed Identifier
    15121737
    Citation
    Lee S, Janssen I, Ross R. Interindividual variation in abdominal subcutaneous and visceral adipose tissue: influence of measurement site. J Appl Physiol (1985). 2004 Sep;97(3):948-54. doi: 10.1152/japplphysiol.01200.2003. Epub 2004 Apr 30.
    Results Reference
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    PubMed Identifier
    16076829
    Citation
    LaMonte MJ, FitzGerald SJ, Church TS, Barlow CE, Radford NB, Levine BD, Pippin JJ, Gibbons LW, Blair SN, Nichaman MZ. Coronary artery calcium score and coronary heart disease events in a large cohort of asymptomatic men and women. Am J Epidemiol. 2005 Sep 1;162(5):421-9. doi: 10.1093/aje/kwi228. Epub 2005 Aug 2.
    Results Reference
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    PubMed Identifier
    16293717
    Citation
    Barlow CE, LaMonte MJ, Fitzgerald SJ, Kampert JB, Perrin JL, Blair SN. Cardiorespiratory fitness is an independent predictor of hypertension incidence among initially normotensive healthy women. Am J Epidemiol. 2006 Jan 15;163(2):142-50. doi: 10.1093/aje/kwj019. Epub 2005 Nov 17.
    Results Reference
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    PubMed Identifier
    16286852
    Citation
    Jurca R, Lamonte MJ, Barlow CE, Kampert JB, Church TS, Blair SN. Association of muscular strength with incidence of metabolic syndrome in men. Med Sci Sports Exerc. 2005 Nov;37(11):1849-55. doi: 10.1249/01.mss.0000175865.17614.74.
    Results Reference
    background
    PubMed Identifier
    16009797
    Citation
    LaMonte MJ, Barlow CE, Jurca R, Kampert JB, Church TS, Blair SN. Cardiorespiratory fitness is inversely associated with the incidence of metabolic syndrome: a prospective study of men and women. Circulation. 2005 Jul 26;112(4):505-12. doi: 10.1161/CIRCULATIONAHA.104.503805. Epub 2005 Jul 11.
    Results Reference
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    Coronary Artery Calcium, Exercise Tests, and CHD Outcome

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