Atherosclerosis Clinical Trial
Official title:
Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study
The study will evaluate the clinical utilization of skin Cholesterol (SC) for cardiovascular
risk assessment in asymptomatic individuals at low, intermediate and high risk based on
Framingham global risk estimates.
Preliminary studies have suggested that SC is an easy to measure, noninvasive marker of
cardiovascular risk. This study is intended to provide further data in support of broader
clearance by the Food and Drug Administration for the use of SC as a tool to identify
asymptomatic patients at increased risk of cardiovascular disease. Currently, SC testing is
cleared for use as part of risk assessment in subject suspected of having significant
multi-vessel disease.
The current study data will be used to support the use of SC testing as part of
cardiovascular risk assessment in subjects without suspected coronary artery disease (CAD).
- The primary objective of the study will be to determine the relationship between skin
cholesterol levels and carotid artery intima-media thickness (CIMT), a surrogate marker
for atherosclerotic burden used as the "gold standard" comparator.
- Secondary objectives of the study will be to compare the skin cholesterol levels with
other markers of CAD as HDL cholesterol, Apo B, hsCRP, and lipoprotein-association
phospholipase A2.
- Another objective is to determine the relationship between skin cholesterol levels and
the presence of carotid plaques detected by ultrasound.
;
Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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