Predictor of Advanced Subclinical Atherosclerosis
1 other identifier
observational
600
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2005
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 26, 2005
CompletedFirst Posted
Study publicly available on registry
October 27, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedJune 6, 2006
June 1, 2006
October 26, 2005
June 5, 2006
Conditions
Eligibility Criteria
You may qualify if:
- Informed written consent from the subject prior to testing.
- Males or females 40-80 years of age
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PreMDlead
Study Sites (6)
Radiant Research
Chicago, Illinois, 60610, United States
University of Chicago
Chicago, Illinois, 60637, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21224, United States
University of Minnesota
Minneapolis, Minnesota, 55415-1226, United States
University od Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Stein, MD
University of Wisconsin, Madison
- PRINCIPAL INVESTIGATOR
Michael Davidson, MD
Radiant Research - Chicago
- PRINCIPAL INVESTIGATOR
Ouyang Pamela, MD
Johns Hopkins University
- PRINCIPAL INVESTIGATOR
Decara Jeanne, MD
University of Chicago
- PRINCIPAL INVESTIGATOR
Mohler Emile, MD
University of Pennsylvania
- PRINCIPAL INVESTIGATOR
Hirsch Alan, MD
University of Minnesota
Study Design
- Study Type
- observational
- Observational Model
- DEFINED POPULATION
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 26, 2005
First Posted
October 27, 2005
Study Start
September 1, 2005
Study Completion
May 1, 2006
Last Updated
June 6, 2006
Record last verified: 2006-06