Trial Outcomes & Findings for Evaluation of Coronary Artery Calcification Using Gated Stationary Chest Tomosynthesis (NCT NCT03169062)

Last Updated: 2020-02-11

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

1 year

Results posted on

2020-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	All Patients Gated Stationary Chest Tomosynthesis 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.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Coronary Artery Calcification Using Gated Stationary Chest Tomosynthesis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=10 Participants Gated Stationary Chest Tomosynthesis 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age, Continuous	76 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Visualization of coronary artery calcium was limited given the small effective angular span of the current hardware, thus calcium scoring was not performed. Since calcium scoring could not be performed, the planned analysis could not be conducted.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Patients n=10 Participants Gated Stationary Chest Tomosynthesis 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.
Mean Correlation Coefficient of Gating	0.87 unitless Standard Deviation 0.09

Adverse Events

All Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Associate Director of Clinical Research Operations, Department of Radiology

University of North Carolina at Chapel Hill

Phone: 919-966-4997

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place