Predictor of Advanced Subclinical Atherosclerosis
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.
|Coronary Artery Disease|
|Study Design:||Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
|Study Start Date:||September 2005|
|Estimated Study Completion Date:||May 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245284
|United States, Illinois|
|Chicago, Illinois, United States, 60610|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21224|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55415-1226|
|United States, Pennsylvania|
|University od Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||James Stein, MD||University of Wisconsin, Madison|
|Principal Investigator:||Michael Davidson, MD||Radiant Research - Chicago|
|Principal Investigator:||Ouyang Pamela, MD||Johns Hopkins University|
|Principal Investigator:||Decara Jeanne, MD||University of Chicago|
|Principal Investigator:||Mohler Emile, MD||University of Pennsylvania|
|Principal Investigator:||Hirsch Alan, MD||University of Minnesota - Clinical and Translational Science Institute|