Status:
COMPLETED
A Study Comparing Skin Fluorescence to Coronary Artery Calcification
Lead Sponsor:
VeraLight, Inc.
Collaborating Sponsors:
New Mexico Heart Institute, PA
Conditions:
Diabetes
Coronary Artery Calcification
Eligibility:
All Genders
45+ years
Brief Summary
This study examines the relationship between the SCOUT DM device and coronary artery calcification as determined by rapid computed tomography in patients at risk for coronary heart disease.
Detailed Description
This is a cross-sectional, single site, cohort screening trial. The correlation between the measured skin fluorescence and the CACS will be determined using a design that includes stratification by ge...
Eligibility Criteria
Inclusion
- Males ≥ 45 years or females ≥ 50 years old that have had a coronary artery calcification score determined by rapid computed tomography at the clinical site within the last six months.
Exclusion
- Receiving investigational treatments
- Psychosocial issues that interfere with an ability to follow study procedures
- Known to be pregnant
- Receiving dialysis or having known renal compromise
- Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
- Recent or current oral steroid therapy or topical steroids applied to the left forearm
- Current chemotherapy, or chemotherapy within the past 12 months
- Receiving medications that fluoresce\*
- Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00895427
Start Date
February 1 2009
End Date
September 1 2011
Last Update
October 12 2011
Active Locations (1)
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1
New Mexico Heart Institute
Albuquerque, New Mexico, United States, 87120