CClinicalTrials.gg
CompletedNCT00895427CACSUpdated Oct 12, 2011

A Study Comparing Skin Fluorescence to Coronary Artery Calcification

An observational study in Diabetes and Coronary Artery Calcification, sponsored by VeraLight, Inc.. Completed at 1 site in United States. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-10-12.

Sponsored by VeraLight, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
240
Ages
45 Years and older
Sex
All
01

Study 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.

Read the 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 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.

02

Conditions studied

  • Diabetes
  • Coronary Artery Calcification

Keywords

  • Coronary artery calcification
03

In context

Arteriosclerosis

317 studies on the registry are indexed under Arteriosclerosis; 33 are open to participants now.

This study's planned enrollment of 240 is below the median of 330 across 99 observational studies indexed under Arteriosclerosis.

Browse Arteriosclerosis studies →

Lead sponsor

VeraLight, Inc. is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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)

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

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)
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
240 participants (estimated)

Groups and cohorts

  • 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

06

Study locations

1 site
  • New Mexico Heart Institute
    Albuquerque, New Mexico 87120, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00895427
Lead sponsor
VeraLight, Inc.
Collaborators
New Mexico Heart Institute, PA
Responsible party
Sponsor
First posted
May 8, 2009
Start date
Feb 2009
Primary completion
Dec 2010
Completion
Sep 2011
Last update
Oct 12, 2011

Study contacts

John Maynard, MS
study director · VeraLight, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion