Evaluation of Coronary Artery Calcification Using Gated Stationary Chest Tomosynthesis

University of North Carolina (UNC)

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Gated Stationary Chest Tomosynthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT03169062

16-1160

Details and patient eligibility

About

The purpose of this study is to propose a new method for evaluating coronary artery calcium scores (CACS) in individuals with coronary artery disease.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

All patients

Experimental group

Description:

Gated Stationary Chest Tomosynthesis

Treatment:

Device: Gated Stationary Chest Tomosynthesis