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

This study has been completed.
Sponsor:
Collaborator:
New Mexico Heart Institute, PA
Information provided by (Responsible Party):
VeraLight, Inc.
ClinicalTrials.gov Identifier:
NCT00895427
First received: May 6, 2009
Last updated: October 7, 2011
Last verified: October 2011
  Purpose

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.


Condition
Diabetes
Coronary Artery Calcification

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Cross-Sectional Study Comparing Noninvasive Skin Fluorescence to Coronary Artery Calcification Measured by Rapid Computed Tomography

Resource links provided by NLM:


Further study details as provided by VeraLight, Inc.:

Estimated Enrollment: 240
Study Start Date: February 2009
Study Completion Date: September 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/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

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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)

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895427

Locations
United States, New Mexico
New Mexico Heart Institute
Albuquerque, New Mexico, United States, 87120
Sponsors and Collaborators
VeraLight, Inc.
New Mexico Heart Institute, PA
Investigators
Study Director: John Maynard, MS VeraLight, Inc.
  More Information

No publications provided

Responsible Party: VeraLight, Inc.
ClinicalTrials.gov Identifier: NCT00895427     History of Changes
Other Study ID Numbers: VL-2709
Study First Received: May 6, 2009
Last Updated: October 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by VeraLight, Inc.:
Coronary artery calcification

Additional relevant MeSH terms:
Calcinosis
Coronary Artery Disease
Arteriosclerosis
Calcium Metabolism Disorders
Metabolic Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014