A Study Comparing Skin Fluorescence to Coronary Artery Calcification

Diabetes Clinical Trial

— CACS  

Official title:

A Cross-Sectional Study Comparing Noninvasive Skin Fluorescence to Coronary Artery Calcification Measured by Rapid Computed Tomography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895427
• Other study ID #: VL-2709
• Status: Completed
• Phase: N/A
• First received: May 6, 2009
• Last updated: October 7, 2011
• Start date: February 2009
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: VeraLight, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 gender, subject age and subject CAC score. This design requires a single patient visit to the clinical site and a single measurement on the SCOUT device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: September 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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)

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arteriosclerosis
• Calcinosis
• Coronary Artery Calcification
• Coronary Artery Disease
• Diabetes

Locations

Country	Name	City	State
United States	New Mexico Heart Institute	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
VeraLight, Inc.	New Mexico Heart Institute, PA

Country where clinical trial is conducted

United States,