Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study

NCT ID: NCT00258999

Last Updated: 2015-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2007-11-30

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.

Conditions

Atherosclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Skin Cholesterol Testing

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James H Stein, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

H-2005-0342

Identifier Type: -

Identifier Source: org_study_id