Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00258999
First received: November 23, 2005
Last updated: December 11, 2007
Last verified: December 2007
  Purpose

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 Intervention
Atherosclerosis
Device: Skin Cholesterol Testing

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

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).

Estimated Enrollment: 600
Study Start Date: October 2005
Study Completion Date: November 2007
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.
  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258999

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

No publications provided

Responsible Party: James H Stein, MD, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00258999     History of Changes
Other Study ID Numbers: H-2005-0342
Study First Received: November 23, 2005
Last Updated: December 11, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
Skin Cholesterol
Carotid Plaque
Carotid Intima-Media Thickness

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014