Evaluation of Coronary Artery Calcification Using Gated Stationary Chest Tomosynthesis

Coronary Artery Disease Clinical Trial

Official title:

Evaluation of Coronary Artery Calcification Using Gated Stationary Chest Tomosynthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03169062
• Other study ID #: 16-1160
• Status: Completed
• Phase: N/A
• Start date: June 26, 2017
• Est. completion date: April 10, 2019

Study information

• Verified date: January 2020
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 10, 2019
• Est. primary completion date: April 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Gated Stationary Chest Tomosynthesis
The technologist will comfortably position the patient laying face up on the imaging table. EKG leads will be placed in appropriate positions to derive an EKG signal. The EKG will be used to trigger the image collection. The subject will be asked to hold his or her breath for 25-30 seconds during the scan. Total patient preparation and imaging time should not exceed 20 minutes.

Locations

Country	Name	City	State
United States	University of North Carolina of Chapel hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of CT Derived CACS and Tomosynthesis Scores Correlation	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	1 year
Secondary	Mean Correlation Coefficient of Gating	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.	At the conclusion of all data collection, 6 months post study completion