Back to resultsPredictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study
Primary Purpose
Atherosclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Skin Cholesterol Testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Atherosclerosis focused on measuring Skin Cholesterol, Carotid Plaque, Carotid Intima-Media Thickness
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)
Sites / Locations
- University of Wisconsin
Outcomes
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).
Full Information
NCT ID
NCT00258999
First Posted
November 23, 2005
Last Updated
October 1, 2015
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT00258999
Brief Title
Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study
Official Title
Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
Skin Cholesterol, Carotid Plaque, Carotid Intima-Media Thickness
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Skin Cholesterol Testing
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James H Stein, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study
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