Predictor of Advanced Subclinical Atherosclerosis
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|ClinicalTrials.gov Identifier: NCT00245284|
Recruitment Status : Completed
First Posted : October 27, 2005
Last Update Posted : June 6, 2006
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.
|Condition or disease|
|Coronary Artery Disease|
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.
|Study Type :||Observational|
|Enrollment :||600 participants|
|Observational Model:||Defined Population|
|Study Start Date :||September 2005|
|Study Completion Date :||May 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|