- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00895427
A Study Comparing Skin Fluorescence to Coronary Artery Calcification (CACS)
October 7, 2011 updated by: VeraLight, Inc.
A Cross-Sectional Study Comparing Noninvasive Skin Fluorescence to Coronary Artery Calcification Measured by Rapid Computed Tomography
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Anticipated)
240
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Mexico
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Albuquerque, New Mexico, United States, 87120
- New Mexico Heart Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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)
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
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
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3
Male ages 65+, without diabetes, CAC score from 0 to >1000
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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
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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
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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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: John Maynard, MS, VeraLight, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
May 6, 2009
First Submitted That Met QC Criteria
May 7, 2009
First Posted (Estimate)
May 8, 2009
Study Record Updates
Last Update Posted (Estimate)
October 12, 2011
Last Update Submitted That Met QC Criteria
October 7, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VL-2709
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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