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OpenTrials
Completed

NCT Number: NCT00245284

Predictor of Advanced Subclinical Atherosclerosis

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Radiant Research, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed written consent from the subject prior to testing.
  • Males or females 40-80 years of age

Exclusion criteria

  • Subjects taking cholesterol-lowering medications
  • Known hepatitis
  • Known pregnancy
  • Skin disease on either hand (e.g. eczema psoriasis, rash or broken skin)
  • 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)

Sponsors and collaborators

Lead sponsor

PreMD

Industry

Registry information

Important dates

Study start
2005
Study completion
2006
First posted
Oct 27, 2005
Registry last updated
Jun 6, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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