A Study Comparing Skin Fluorescence to Coronary Artery Calcification

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00895427

Acronym

CACS

Enrollment

240

Registered

2009-05-08

Start date

2009-02-28

Completion date

2011-09-30

Last updated

2011-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Calcification, Diabetes

Keywords

Coronary artery calcification

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

Yes

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)

Countries

United States

Outcome results