Coronary Artery Disease Clinical Trial
Evaluation of skin cholesterol for cardiovascular risk assessment in asymptomatic
individuals at low, intermediate, or high risk based on Framingham Global Risk estimates.
Carotid intima-media thickness (IMT), a surrogate marker for atherosclerotic burden, that
independently predicts the occurrence of heart attack and stroke, will be the “gold
standard” comparator.
Hypothesis: Skin cholesterol, as measured by two non-invasive tests, correlates with CAD, as
measured by CIMT in this population.
This study will enroll 600 asymptomatic subjects at low (<6%), intermediate (6-20% ), or
high (>20%) 10-year Framingham global cardiovascular risk in approximately equal
proportions.
Subjects will be enrolled from each of the three risk levels at each study site (6 total in
the US). Subjects will be enrolled in a consecutive manner until there are 200 subjects from
each risk level. We will track the number of subjects from each risk stratum. We will also
ensure adequate representation of women (at least 33%) and African Americans (at least
25%)in the study.
We will test the subjects with 2 non-invasive skin cholesterol tests and will take a sample
of blood that will be tested for serum cholesterol values and other markers of CAD. Subjects
will also undego a carotid IMT scan.
The primary objective of the study is to see if skin cholesterol correlates with CAD, as
measured by CIMT.
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Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional
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