Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study - Full Text View

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00258999

Purpose

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

Drug Information available for: Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

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

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

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 Outcome Measures:

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).

Estimated Enrollment:	600
Study Start Date:	October 2005
Study Completion Date:	November 2007

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

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258999

Locations

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:

James H Stein, MD

University of Wisconsin, Madison

More Information

Responsible Party:	University of Wisconsin ( James H Stein, MD )
Study ID Numbers:	H-2005-0342
Study First Received:	November 23, 2005
Last Updated:	December 11, 2007
ClinicalTrials.gov Identifier:	NCT00258999
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:

Skin Cholesterol
Carotid Plaque
Carotid Intima-Media Thickness

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Vascular Diseases
Arteriosclerosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009