Clinical trial NCT00245284: Predictor of Advanced Subclinical Atherosclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: PreMD
Sponsor class: INDUSTRY
First posted: 2005-10-27
Enrollment: 600
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

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.

Eligibility 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Radiant Research
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Philadelphia
country: United States
facility: University od Pennsylvania
state: Pennsylvania
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: James Stein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiant Research - Chicago
name: Michael Davidson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Ouyang Pamela, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Decara Jeanne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Mohler Emile, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Hirsch Alan, MD
role: PRINCIPAL_INVESTIGATOR
References: