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

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ClinicalTrials.gov Identifier: NCT00895427
Recruitment Status : Completed
First Posted : May 8, 2009
Last Update Posted : October 12, 2011
Sponsor:
Collaborator:
New Mexico Heart Institute, PA
Information provided by (Responsible Party):
VeraLight, Inc.

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.

Condition or disease
Diabetes Coronary Artery Calcification

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.

Study Type : Observational
Estimated Enrollment : 240 participants
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
Study Start Date : February 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Group/Cohort
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




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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: VeraLight, Inc.
ClinicalTrials.gov Identifier: NCT00895427     History of Changes
Other Study ID Numbers: VL-2709
First Posted: May 8, 2009    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011

Keywords provided by VeraLight, Inc.:
Coronary artery calcification

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