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Predictor of Advanced Subclinical Atherosclerosis

This study has been completed.
Sponsor:
Information provided by:
PreMD
ClinicalTrials.gov Identifier:
NCT00245284
First received: October 26, 2005
Last updated: June 5, 2006
Last verified: June 2006
History of Changes
  Purpose

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
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by PreMD:

Estimated Enrollment: 600
Study Start Date: September 2005
Estimated Study Completion Date: May 2006
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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245284

Locations
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
PreMD
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00245284     History of Changes
Other Study ID Numbers: 04K1 - PASA
Study First Received: October 26, 2005
Last Updated: June 5, 2006
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2013