Predictor of Advanced Subclinical Atherosclerosis

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245284
• Other study ID #: 04K1 - PASA
• Status: Completed
• Phase: N/A
• First received: October 26, 2005
• Last updated: June 5, 2006
• Start date: September 2005
• Est. completion date: May 2006

Study information

• Verified date: June 2006
• Source: PreMD
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Radiant Research	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Wisconsin	Madison	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	University od Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
PreMD

Country where clinical trial is conducted

United States,