Predictor of Advanced Subclinical Atherosclerosis

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. Identifier: NCT00245284
Recruitment Status : Completed
First Posted : October 27, 2005
Last Update Posted : June 6, 2006
Information provided by:

Brief Summary:

Evaluation of skin cholesterol for cardiovascular risk assessment in asymptomatic individuals at low, intermediate, or high risk based on Framingham Global Risk estimates. Carotid intima-media thickness (IMT), a surrogate marker for atherosclerotic burden, that independently predicts the occurrence of heart attack and stroke, will be the “gold standard” comparator.

Hypothesis: Skin cholesterol, as measured by two non-invasive tests, correlates with CAD, as measured by CIMT in this population.

Condition or disease
Coronary Artery Disease

Detailed Description:

This study will enroll 600 asymptomatic subjects at low (<6%), intermediate (6-20% ), or high (>20%) 10-year Framingham global cardiovascular risk in approximately equal proportions.

Subjects will be enrolled from each of the three risk levels at each study site (6 total in the US). Subjects will be enrolled in a consecutive manner until there are 200 subjects from each risk level. We will track the number of subjects from each risk stratum. We will also ensure adequate representation of women (at least 33%) and African Americans (at least 25%)in the study.

We will test the subjects with 2 non-invasive skin cholesterol tests and will take a sample of blood that will be tested for serum cholesterol values and other markers of CAD. Subjects will also undego a carotid IMT scan.

The primary objective of the study is to see if skin cholesterol correlates with CAD, as measured by CIMT.

Study Type : Observational
Enrollment : 600 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Study Start Date : September 2005
Study Completion Date : May 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Informed written consent from the subject prior to testing.
  2. Males or females 40-80 years of age

Exclusion Criteria:

  1. Subjects taking cholesterol-lowering medications
  2. Known hepatitis
  3. Known pregnancy
  4. Skin disease on either hand (e.g. eczema psoriasis, rash or broken skin)
  5. Known CAD (previous myocardial infarction, coronary revascularization procedure), cerebrovascular disease (previous stroke, transient ischemic attack, or carotid revascularization procedure), or peripheral arterial disease(claudication or previous revascularization procedure)

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 identifier (NCT number): NCT00245284

United States, Illinois
Radiant Research
Chicago, Illinois, United States, 60610
University of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21224
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55415-1226
United States, Pennsylvania
University od Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Principal Investigator: James Stein, MD University of Wisconsin, Madison
Principal Investigator: Michael Davidson, MD Radiant Research - Chicago
Principal Investigator: Ouyang Pamela, MD Johns Hopkins University
Principal Investigator: Decara Jeanne, MD University of Chicago
Principal Investigator: Mohler Emile, MD University of Pennsylvania
Principal Investigator: Hirsch Alan, MD University of Minnesota - Clinical and Translational Science Institute Identifier: NCT00245284     History of Changes
Other Study ID Numbers: 04K1 - PASA
First Posted: October 27, 2005    Key Record Dates
Last Update Posted: June 6, 2006
Last Verified: June 2006

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases