Predictor of Advanced Subclinical Atherosclerosis

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT00245284
• Lead Sponsor: PreMD

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.

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 Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-10-26
• Study First Submitted QC: 2005-10-26
• Study First Posted: 2005-10-27
• Study Completion: 2006-05
• Status Verified: 2006-06
• Last Update Submitted: 2006-06-05
• Last Update Posted: 2006-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

University od Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Radiant Research; 🇺🇸 Chicago, Illinois, United States