MedDataX Logo

Predictor of Advanced Subclinical Atherosclerosis

NCT ID: NCT00245284

Last Updated: 2006-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

PreMD

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

James Stein, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Michael Davidson, MD

Role: PRINCIPAL_INVESTIGATOR

Radiant Research - Chicago

Ouyang Pamela, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Decara Jeanne, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Mohler Emile, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Hirsch Alan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Radiant Research

Chicago, Illinois, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

University od Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

04K1 - PASA

Identifier Type: -

Identifier Source: org_study_id