Clinical trial NCT00258999: Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study
Official title: Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Keywords: Skin Cholesterol
Carotid Plaque
Carotid Intima-Media Thickness
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-11-28
Enrollment: 600
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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).

Detailed description: * 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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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)
Secondary outcomes:
measure: 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).
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: James H Stein, MD
role: PRINCIPAL_INVESTIGATOR
References: