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Sponsored by: |
University of Wisconsin, Madison |
Information provided by: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00258999 |
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).
Condition | Intervention |
Atherosclerosis |
Device: Skin Cholesterol Testing |
MedlinePlus related topics: | Cholesterol |
ChemIDplus related topics: | Cholest-5-en-3-ol (3beta)- |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Bio-equivalence Study |
Official Title: | Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study |
Estimated Enrollment: | 600 |
Study Start Date: | October 2005 |
Study Completion Date: | November 2007 |
Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Wisconsin | |||||
University of Wisconsin | |||||
Madison, Wisconsin, United States, 53792 |
University of Wisconsin, Madison |
Principal Investigator: | James H Stein, MD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin ( James H Stein, MD ) |
Study ID Numbers: | H-2005-0342 |
First Received: | November 23, 2005 |
Last Updated: | December 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00258999 |
Health Authority: | United States: Food and Drug Administration |
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