Coronary Artery DiseaseNCT03169062
Evaluation of Coronary Artery Calcification Using Gated Stationary Chest Tomosynthesis
A study testing Gated Stationary Chest Tomosynthesis in people with Coronary Artery Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to propose a new method for evaluating coronary artery calcium scores (CACS) in individuals with coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Gated Stationary Chest Tomosynthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2017to 10 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: ≥18 years of age
- Intermediate Framingham Risk Score of 10 to 20% risk over the next 10 years
- Previous non-contrast enhanced chest CT in a time frame that will accommodate experimental imaging (CG-SDCT) within 4 weeks. This imaging may have already been completed at the time of enrollment or may be scheduled in the future at the time of enrollment.
- IRB written informed consent obtained and signed Exclusion Criteria
- Negative urine pregnancy test in women of child-bearing potential (WCBP) within 1 week prior to s-DCT.
Who cannot join
- Unable to provide consent
- Pregnant or lactating
- BMI > 33 (Patient who may not fit on a 35 x 35 detector) (Images are not clear on subjects who have a greater than 33 BMI)
- Previous history of MI or thoracic surgery.
- Disability that could interfere with the scanning process, non-ambulatory or unable to hold their breath for up to 30 seconds.
- Planned procedures or therapies in between non-contrast CT scan and study Chest tomosynthesis scan, e.g., line placement in the chest region, biopsy, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina of Chapel hill
Chapel Hill, North Carolina, 27599-7510
About this study
The purpose of this study is to propose a new method for evaluating coronary artery calcium scores (CACS) in individuals with coronary artery disease.
Read the detailed description
The proposed research, if successfully implemented, will result in a new method for evaluating coronary artery calcium scores (CACS) in individuals with coronary artery disease. Using the Cardiac Gated Stationary Chest Tomosynthesis (CG-SDCT) system the imaging dose for a a full tomosynthesis scan is expected to be only 10% of that from a low-dose CT. The targeted imaging time of 25-30 seconds is 1/2 of that from a current commercial DCT system at the same imaging dose. As with current commercial DCT systems, our s-DCT system will expose patients to less radiation and deliver comparable data for CACS. CG-SDCT will likely result in accurate CAC scoring and allow for a more complete patient risk assessment as compared to Framingham risk scoring alone.
- Conditions
- Coronary Artery Disease
- Being tested
- Gated Stationary Chest Tomosynthesis
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gated Stationary Chest TomosynthesisDevice
The technologist will comfortably position the patient laying face up on the imaging table. EKG leads will be placed in appropriate positions to derive an EKG signal. The EKG will be used to trigger the image collection. The subject will be asked to hold his or her breath for 25-30 seconds during the scan. Total patient preparation and imaging time should not exceed 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | Gated Stationary Chest Tomosynthesis Receives: Device: Gated Stationary Chest Tomosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of CT Derived CACS and Tomosynthesis Scores Correlation
Linear regression and Bland-Altman analysis will be used to examine the relationship between the CT derived CACS and tomosynthesis scores to determine the correlation
Measured: 1 year
Secondary outcomes (1)
Mean Correlation Coefficient of Gating
The 30 ms cardiac EKG trace will be extracted for each of the projections. Then, a Pearson correlation coefficient will be calculated for each of the projections relative to the first x-ray projection. The mean of the Pearson correlation coefficients will then calculated and served as an estimate of the timing precision of each projection set for each patient. The mean and standard deviation of the correlation coefficients will be reported.
Measured: At the conclusion of all data collection, 6 months post study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start26 Jun 2017
- Primary completion10 Apr 2019
- Study completion10 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yueh Lee, M.D, Principal investigator, University of North Carolina of Chapel hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169062
- Sponsor's protocol ID
- 16-1160
- Status last verified
- Jan 2020
- First submitted
- 23 May 2017
- Last updated
- 11 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Coronary Artery Calcification Using Gated Stationary Chest Tomosynthesis
- ClinicalTrials.gov ID
- NCT03169062
- Acronym / sponsor ID
- 16-1160
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Posted 11 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to propose a new method for evaluating coronary artery calcium scores (CACS) in individuals with coronary artery disease.
Detailed description
The proposed research, if successfully implemented, will result in a new method for evaluating coronary artery calcium scores (CACS) in individuals with coronary artery disease. Using the Cardiac Gated Stationary Chest Tomosynthesis (CG-SDCT) system the imaging dose for a a full tomosynthesis scan is expected to be only 10% of that from a low-dose CT. The targeted imaging time of 25-30 seconds is 1/2 of that from a current commercial DCT system at the same imaging dose. As with current commercial DCT systems, our s-DCT system will expose patients to less radiation and deliver comparable data for CACS. CG-SDCT will likely result in accurate CAC scoring and allow for a more complete patient risk assessment as compared to Framingham risk scoring alone.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Device: Gated Stationary Chest TomosynthesisGated Stationary Chest Tomosynthesis |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age range: ≥18 years of age
- Intermediate Framingham Risk Score of 10 to 20% risk over the next 10 years
- Previous non-contrast enhanced chest CT in a time frame that will accommodate experimental imaging (CG-SDCT) within 4 weeks. This imaging may have already been completed at the time of enrollment or may be scheduled in the future at the time of enrollment.
- IRB written informed consent obtained and signed Exclusion Criteria
- Negative urine pregnancy test in women of child-bearing potential (WCBP) within 1 week prior to s-DCT.
Key exclusion criteria (6 listed)
- Unable to provide consent
- Pregnant or lactating
- BMI > 33 (Patient who may not fit on a 35 x 35 detector) (Images are not clear on subjects who have a greater than 33 BMI)
- Previous history of MI or thoracic surgery.
- Disability that could interfere with the scanning process, non-ambulatory or unable to hold their breath for up to 30 seconds.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gated Stationary Chest TomosynthesisThe technologist will comfortably position the patient laying face up on the imaging table. EKG leads will be placed in appropriate positions to derive an EKG signal. The EKG will be used to trigger the image collection. The subject will be asked to hold his or her breath for 25-30 seconds during the scan. Total patient preparation and imaging time should not exceed 20 minutes. | Device | All patients |
Primary outcome
Comparison of CT Derived CACS and Tomosynthesis Scores Correlation
Time frame: 1 year
Linear regression and Bland-Altman analysis will be used to examine the relationship between the CT derived CACS and tomosynthesis scores to determine the correlation
1 secondary outcome
Mean Correlation Coefficient of Gating
Time frame: At the conclusion of all data collection, 6 months post study completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Yueh Lee, M.D principal investigator
University of North Carolina of Chapel hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gated Stationary Chest Tomosynthesis in people with Coronary Artery Disease, run by University of North Carolina, Chapel Hill 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 5 inclusion and 6 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 11 Feb 2020. 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?
Yes. Results are posted in the registry (first posted 11 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Comparison of CT Derived CACS and Tomosynthesis Scores Correlation (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 11 Feb 2020.