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Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 23, 2005
First Posted Date  ICMJE November 28, 2005
Last Update Posted Date October 5, 2015
Study Start Date  ICMJE October 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2005)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2005)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study
Official Title  ICMJE Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Atherosclerosis
Intervention  ICMJE Device: Skin Cholesterol Testing
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: November 23, 2005)
600
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00258999
Other Study ID Numbers  ICMJE H-2005-0342
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James H Stein, MD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP