Predictor of Advanced Subclinical Atherosclerosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00245284

Enrollment

600

Registered

2005-10-27

Start date

2005-09-30

Completion date

2006-05-31

Last updated

2006-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

None listed

Study design

Observational model

DEFINED_POPULATION

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

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)

Countries

United States

Outcome results