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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study|
- The primary analysis will test if SC is a predictor of elevated CIMT (i.e. carotid wall thickness above the 75% percentile expected for subject's age sex and race based on projections from the Atherosclerosis Risk in Communities Study)
- Secondarily, estimates of relative risk will allow the comparison of the power of SC as a predictor and traditional risk and new emerging risk factors(hsCRP, Apo B100 and Phospholipase A2).
|Study Start Date:||October 2005|
|Study Completion Date:||November 2007|
- 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.
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||James H Stein, MD||University of Wisconsin, Madison|