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| Name | Class |
|---|---|
| New Mexico Heart Institute, PA | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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)
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| Name | Affiliation | Role |
|---|---|---|
| John Maynard, MS | VeraLight, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Mexico Heart Institute | Albuquerque | New Mexico | 87120 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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 |