Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study

Atherosclerosis Clinical Trial

Official title:

Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258999
• Other study ID #: H-2005-0342
• Status: Completed
• Phase: N/A
• First received: November 23, 2005
• Last updated: October 1, 2015
• Start date: October 2005
• Est. completion date: November 2007

Study information

• Verified date: December 2007
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Device:
• Skin Cholesterol Testing

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).