A Study Comparing Skin Fluorescence to Coronary Artery Calcification (CACS)

VeraLight

Status: Completed

Conditions: Diabetes; Coronary Artery Calcification

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00895427

VL-2709

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

240 participants in 12 patient groups

1

Description:

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

2

Description:

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

3

Description:

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

4

Description:

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

5

Description:

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

6

Description:

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

7

Description:

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

8

Description:

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

9

Description:

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

10

Description:

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

11

Description:

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

12

Description:

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