A Study Comparing Skin Fluorescence to Coronary Artery Calcification

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Cross-Sectional Study Comparing Noninvasive Skin Fluorescence to Coronary Artery Calcification Measured by Rapid Computed Tomography

Conditions
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Diabetes, Coronary Artery Calcification

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Male ages 45-54, without diabetes, CAC score from 0 to >1000 | |
| 2<br>Male ages 55-64, without diabetes, CAC score from 0 to >1000 | |
| 3<br>Male ages 65+, without diabetes, CAC score from 0 to >1000 | |
| 4<br>Male ages 45-54, with diabetes and CAC score from 0 to >1000 | |
| 5<br>Male ages 55-64, with diabetes, CAC score from 0 to >1000 | |
| 6<br>Male ages 65+, with diabetes, CAC score from 0 to >1000 | |
| 7<br>Female ages 50-59, without diabetes, CAC score from 0 to >1000 | |
| 8<br>Females ages 60-69, without diabetes and CAC score from 0 to >1000 | |
| 9<br>Females ages 70 +, without diabetes, CAC score from 0 to >1000 | |
| 10<br>Female ages 50- 59, with diabetes, CAC score from 0 to >1000 | |
| 11<br>Female ages 60-69, with diabetes, CAC score from 0 to >1000 | |
| 12<br>Female age 70+, with diabetes, CAC score from 0 to >1000 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery calcification