N/A
N=10
Evaluation of Coronary Artery Calcification Using Gated Stationary Chest Tomosynthesis
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT03169062 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Comparison of CT Derived CACS and Tomosynthesis Scores Correlation
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gated Stationary Chest Tomosynthesis (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of CT Derived CACS and Tomosynthesis Scores Correlation |
— | — |
| SECONDARY Mean Correlation Coefficient of Gating |
0.87 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03169062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.