Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 30 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | October 2005 |
| End Date: | November 2007 |
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).
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.
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.
Inclusion Criteria:
- Informed written consent from the subject prior to testing.
- Males or females 30-80 years of age
Exclusion Criteria:
- 1. Known coronary heart disease, (history of myocardial infarction, coronary bypass
surgery, coronary angioplasty, or angina pectoris with a positive stress test or
angiographic documentation)
- Known peripheral vascular disease (claudication with ankle-brachial index < 0.9,
angioplasty, or peripheral artery bypass procedure)
- Known cerebrovascular disease (stroke or TIA with documented carotid or aortic
atherosclerosis)
- History of carotid artery endarterectomy or carotid artery surgery
- Diabetes mellitus (fasting glucose > 126 mg/dL, on on insulin-reducing medications)
- 10-year Framingham risk of cardiac death or MI using ATP III calculator >20%
- Subjects taking cholesterol-lowering medications
- Known hepatitis
- Known pregnancy
- Skin disease on either hand (e.g. eczema psoriasis, rash or broken skin)
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