Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study

NCT00258999 | Completed

• 1 other identifier: H-2005-0342
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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).

Conditions

Atherosclerosis

Keywords

Skin Cholesterol; Carotid Plaque; Carotid Intima-Media Thickness

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• 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).

Interventions

Skin Cholesterol Testing DEVICE

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed written consent from the subject prior to testing.
• Males or females 30-80 years of age

You may not qualify if:

• \. 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)
• 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• James H Stein, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2005
• First Posted: November 28, 2005
• Study Start: October 1, 2005
• Study Completion: November 1, 2007
• Last Updated: October 5, 2015

Record last verified: 2007-12

Locations

US (1)