Cardiovascular Diseases Clinical Trial
Using subjects from the Rochester Family Heart Study (RFHS), to characterize predictors of coronary artery calcification (CAC), a potent marker of atherosclerosis, among individuals from the general population.
BACKGROUND:
Coronary artery disease (CAD) is a major cause of mortality and morbidity in the United
States. Current noninvasive methods to identify individuals with atherosclerosis, such as
exercise testing, are often insensitive until plaques have progressed enough to
significantly impede blood flow or impair myocardial function. A large number of individuals
destined to die suddenly or to experience myocardial infarction will experience no warning
symptoms, having only mild non-flow limiting lesions which rupture and cause occlusive clot.
Since coronary artery calcification (CAC) can identify individuals with mild, non-flow
limiting lesions, CAC is a potent marker of atherosclerosis. The presence of calcium in
mild, non-flow limiting lesions is hypothesized to be a predictor of coronary events in
asymptomatic adults. Ultrafast Cardiac Computed Tomography (Ultrafast CT) provides a tool to
obtain sensitive, noninvasive measures of both the presence and quantity of CAC.
DESIGN NARRATIVE:
Beginning in 1991, the study sought to establish if age and gender predict coronary artery
calcification, a potent marker of atherosclerosis, in individuals who were sampled by the
RFHS and who reported no symptoms of coronary artery disease. The study also sought to
establish: if measures of lipid metabolism provide additional information in predicting CAC
after accounting for variation in age and gender; if measures of blood pressure, body size,
fat distribution, or smoking predict CAC after accounting for variation in age, gender, and
measures of lipid metabolism; if the quantity of CAC aggregates in families; whether the
predictors of CAC in asymptomatic individuals differ from predictors in those with symptoms
of coronary artery disease. Ultrafast Cardiac Computed Tomography (Ultrafast CT) was used to
obtain sensitive, noninvasive measures of both the presence and quantity of CAC.
The study was renewed in 2001 through February 2005 to: determine whether CAC predicts
clinical events after 7.5 years of active followup; identify genetic determinants of change
in CAC quantity; assess whether these genes act through measurable coronary artery disease
risk factors. The full sample of 1,647 asymptomatic at baseline adults will be followed
prospectively for clinical endpoints, while CAC quantity will be re-evaluated in a sub
sample of 1,000 individuals.
The influence of newer inflammatory markers such as fibrinogen, C-reactive protein and
antibodies to infective agents will be evaluated.
;
Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional
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