Evaluation of Coronary Artery Calcification Using Gated Stationary Chest Tomosynthesis



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 100
Updated:2/2/2019
Start Date:June 26, 2017
End Date:December 2020
Contact:Doreen Steed, R.T.(R)(M), RA
Email:doreen_steed@med.unc.edu
Phone:(919) 966-9284

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

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.

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.
We found this trial at
1
site
Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Yueh Lee, M.D.
Phone: 919-843-3670
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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