A Study Comparing Skin Fluorescence to Coronary Artery Calcification

NCT00895427 | Completed

• 1 other identifier: VL-2709
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Coronary Artery Calcification

Keywords

Coronary artery calcification

Study Arms (12)

1

Male ages 45-54, without diabetes, CAC score from 0 to \>1000

2

Male ages 55-64, without diabetes, CAC score from 0 to \>1000

3

Male ages 65+, without diabetes, CAC score from 0 to \>1000

4

Male ages 45-54, with diabetes and CAC score from 0 to \>1000

5

Male ages 55-64, with diabetes, CAC score from 0 to \>1000

6

Male ages 65+, with diabetes, CAC score from 0 to \>1000

7

Female ages 50-59, without diabetes, CAC score from 0 to \>1000

8

Females ages 60-69, without diabetes and CAC score from 0 to \>1000

9

Females ages 70 +, without diabetes, CAC score from 0 to \>1000

10

Female ages 50- 59, with diabetes, CAC score from 0 to \>1000

11

Female ages 60-69, with diabetes, CAC score from 0 to \>1000

12

Female age 70+, with diabetes, CAC score from 0 to \>1000

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects are sorted into the follwoing categories for age (years): men:45-54,55-64,65+, women: 50-59, 60-69, 70+. In addition, subjects will be sorted into the follwoing categories for CACS:0-10, 11-100, 101-400, 401-1000, \>1000 and absence/presence of diagnosed diabetes (type 1 or type 2)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• VeraLight, Inc.: lead
• New Mexico Heart Institute, PA: collaborator

Study Sites (1)

New Mexico Heart Institute

Albuquerque, New Mexico, 87120, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• John Maynard, MS

  VeraLight, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2009
• First Posted: May 8, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: September 1, 2011
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

US (1)