DiabetesCACSNCT00895427
A Study Comparing Skin Fluorescence to Coronary Artery Calcification
An observational study of Diabetes and Coronary Artery Calcification, run by VeraLight, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Coronary Artery Calcification
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
New Mexico Heart Institute
Albuquerque, New Mexico, 87120
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes, Coronary Artery Calcification
- Keywords
- Coronary artery calcification
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VeraLight, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- New Mexico Heart Institute, PA
- Responsible party
- Sponsor
- Investigators
- John Maynard, MS, Study director, VeraLight, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895427
- Sponsor's protocol ID
- VL-2709
- Acronym
- CACS
- Status last verified
- Oct 2011
- First submitted
- 6 May 2009
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-Sectional Study Comparing Noninvasive Skin Fluorescence to Coronary Artery Calcification Measured by Rapid Computed Tomography
- ClinicalTrials.gov ID
- NCT00895427
- Acronym / sponsor ID
- CACS / VL-2709
- Conditions
- Diabetes, Coronary Artery Calcification
- Keywords
- Coronary artery calcification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- VeraLight, Inc.Industry (pharma, biotech, devices)
- Collaborators
- New Mexico Heart Institute, PA
- Study start
- Feb 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 8 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| 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 | – | –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 |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Maynard, MS study director
VeraLight, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Coronary Artery Calcification, run by VeraLight, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2011.