Evaluation of Coronary Artery Calcification Using Gated Stationary Chest Tomosynthesis

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
All patients	Gated Stationary Chest Tomosynthesis	Gated Stationary Chest Tomosynthesis

Primary Outcome Measures

Name	Time	Method
Comparison of CT Derived CACS and Tomosynthesis Scores Correlation	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

Secondary Outcome Measures

Name	Time	Method
Mean Correlation Coefficient of Gating	At the conclusion of all data collection, 6 months post study completion	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.