Clinical trial NCT03169062: Evaluation of Coronary Artery Calcification Using Gated Stationary Chest Tomosynthesis
Official title: Evaluation of Coronary Artery Calcification Using Gated Stationary Chest Tomosynthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age range: ≥18 years of age
2. Intermediate Framingham Risk Score of 10 to 20% risk over the next 10 years
3. 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.
4. IRB written informed consent obtained and signed Exclusion Criteria
5. Negative urine pregnancy test in women of child-bearing potential (WCBP) within 1 week prior to s-DCT.

Exclusion Criteria:

1. Unable to provide consent
2. Pregnant or lactating
3. 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)
4. Previous history of MI or thoracic surgery.
5. Disability that could interfere with the scanning process, non-ambulatory or unable to hold their breath for up to 30 seconds.
6. 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.

Primary outcomes:
measure: Comparison of CT Derived CACS and Tomosynthesis Scores Correlation
timeFrame: 1 year
Secondary outcomes:
measure: Mean Correlation Coefficient of Gating
timeFrame: At the conclusion of all data collection, 6 months post study completion
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina of Chapel hill
state: North Carolina
Study officials:
affiliation: University of North Carolina of Chapel hill
name: Yueh Lee, M.D
role: PRINCIPAL_INVESTIGATOR
References: