Cardiovascular Diseases Clinical Trial
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.
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.
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N/A
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