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Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study

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ClinicalTrials.gov Identifier: NCT00258999
Recruitment Status : Completed
First Posted : November 28, 2005
Last Update Posted : October 5, 2015
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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).


Condition or disease Intervention/treatment Phase
Atherosclerosis Device: Skin Cholesterol Testing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study
Study Start Date : October 2005
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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).


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258999


Locations
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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: James H Stein, MD University of Wisconsin, Madison

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00258999    
Other Study ID Numbers: H-2005-0342
First Posted: November 28, 2005    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: December 2007
Keywords provided by University of Wisconsin, Madison:
Skin Cholesterol
Carotid Plaque
Carotid Intima-Media Thickness
Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases