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A Study Comparing Skin Fluorescence to Coronary Artery Calcification

NCT ID: NCT00895427

Last Updated: 2011-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-09-30

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.

Conditions

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Diabetes Coronary Artery Calcification

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Male ages 45-54, without diabetes, CAC score from 0 to \>1000

No interventions assigned to this group

2

Male ages 55-64, without diabetes, CAC score from 0 to \>1000

No interventions assigned to this group

3

Male ages 65+, without diabetes, CAC score from 0 to \>1000

No interventions assigned to this group

4

Male ages 45-54, with diabetes and CAC score from 0 to \>1000

No interventions assigned to this group

5

Male ages 55-64, with diabetes, CAC score from 0 to \>1000

No interventions assigned to this group

6

Male ages 65+, with diabetes, CAC score from 0 to \>1000

No interventions assigned to this group

7

Female ages 50-59, without diabetes, CAC score from 0 to \>1000

No interventions assigned to this group

8

Females ages 60-69, without diabetes and CAC score from 0 to \>1000

No interventions assigned to this group

9

Females ages 70 +, without diabetes, CAC score from 0 to \>1000

No interventions assigned to this group

10

Female ages 50- 59, with diabetes, CAC score from 0 to \>1000

No interventions assigned to this group

11

Female ages 60-69, with diabetes, CAC score from 0 to \>1000

No interventions assigned to this group

12

Female age 70+, with diabetes, CAC score from 0 to \>1000

No interventions assigned to this group

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)
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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New Mexico Heart Institute, PA

OTHER

Sponsor Role collaborator

VeraLight, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Maynard, MS

Role: STUDY_DIRECTOR

VeraLight, Inc.

Locations

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New Mexico Heart Institute

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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VL-2709

Identifier Type: -

Identifier Source: org_study_id