Trial Outcomes & Findings for Deep-Learning Image Reconstruction in CCTA (NCT NCT03980470)

NCT ID: NCT03980470

Last Updated: 2021-11-24

Results Overview

Subjective image quality as measured by Likert scale from 1 (non-evaluable) to 5 (excellent)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: Day 1
• Results posted on: 2021-11-24

Participant Flow

Recruitment period: 08/May/2019 until 20/June/2019 Location: University Hospital Zurich, Department of Nuclear Medicine, Switzerland

Participant milestones

Measure	Normal-dose Versus Low-dose The standard intervention consists of the routinely performed cardiac CT datasets reconstructed with a standard iterative reconstruction algorithm (ASIR-V). Median radiation dose is about 0.5 mSv, range between about 0.2 and 1.2 mSv; median contrast agent administration about 45 mL, range between 35 and 55 mL. The experimental intervention is an additional CT scan with a lower dose (about 20 to 50% decrease) and a similar contrast agent administration that is reconstructed with a deep-learning image reconstruction immediately after the clinical CT scan. The additional time required is about 5 minutes.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Deep-Learning Image Reconstruction in CCTA

Baseline characteristics by cohort

Measure	Normal-dose Versus Low-dose n=50 Participants The standard intervention consists of the routinely performed cardiac CT datasets reconstructed with a standard iterative reconstruction algorithm (ASIR-V). Median radiation dose is about 0.5 mSv, range between about 0.2 and 1.2 mSv; median contrast agent administration about 45 mL, range between 35 and 55 mL. The experimental intervention is an additional CT scan with a lower dose (about 20 to 50% decrease) and a similar contrast agent administration that is reconstructed with a deep-learning image reconstruction immediately after the clinical CT scan. The additional time required is about 5 minutes.
Age, Continuous	59 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	43 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	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Switzerland	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Subjective image quality as measured by Likert scale from 1 (non-evaluable) to 5 (excellent)

Outcome measures

Measure	Normal-dose Versus Low-dose n=50 Participants The standard intervention consists of the routinely performed cardiac CT datasets reconstructed with a standard iterative reconstruction algorithm (ASIR-V). Median radiation dose is about 0.5 mSv, range between about 0.2 and 1.2 mSv; median contrast agent administration about 45 mL, range between 35 and 55 mL. The experimental intervention is an additional CT scan with a lower dose (about 20 to 50% decrease) and a similar contrast agent administration that is reconstructed with a deep-learning image reconstruction immediately after the clinical CT scan. The additional time required is about 5 minutes.
Subjective Image Quality Low-Dose	5 Score on a Likert scale (0-5) 5=best Standard Deviation 0
Subjective Image Quality Normal-Dose	5 Score on a Likert scale (0-5) 5=best Standard Deviation 0

SECONDARY outcome

Timeframe: Day 1

Signal intensity as average hounsfield units within a region of interest in the aortic root, change from experimental interventional to the control intervention

Outcome measures

Measure	Normal-dose Versus Low-dose n=50 Participants The standard intervention consists of the routinely performed cardiac CT datasets reconstructed with a standard iterative reconstruction algorithm (ASIR-V). Median radiation dose is about 0.5 mSv, range between about 0.2 and 1.2 mSv; median contrast agent administration about 45 mL, range between 35 and 55 mL. The experimental intervention is an additional CT scan with a lower dose (about 20 to 50% decrease) and a similar contrast agent administration that is reconstructed with a deep-learning image reconstruction immediately after the clinical CT scan. The additional time required is about 5 minutes.
Signal Intensity Low-Dose	462 Hounsfield units Standard Deviation 76
Signal Intensity Normal Dose	443 Hounsfield units Standard Deviation 85

SECONDARY outcome

Timeframe: Day 1

Image noise as standard deviation of hounsfield units within a region of interest in the aortic root, change from experimental interventional to the control intervention

Outcome measures

Measure	Normal-dose Versus Low-dose n=50 Participants The standard intervention consists of the routinely performed cardiac CT datasets reconstructed with a standard iterative reconstruction algorithm (ASIR-V). Median radiation dose is about 0.5 mSv, range between about 0.2 and 1.2 mSv; median contrast agent administration about 45 mL, range between 35 and 55 mL. The experimental intervention is an additional CT scan with a lower dose (about 20 to 50% decrease) and a similar contrast agent administration that is reconstructed with a deep-learning image reconstruction immediately after the clinical CT scan. The additional time required is about 5 minutes.
Image Noise Low-Dose	27 Hounsfield units Standard Deviation 4
Image Noise Normal-Dose	28 Hounsfield units Standard Deviation 6

SECONDARY outcome

Timeframe: Day 1

Signal-to-noise ratio

Outcome measures

Measure	Normal-dose Versus Low-dose n=50 Participants The standard intervention consists of the routinely performed cardiac CT datasets reconstructed with a standard iterative reconstruction algorithm (ASIR-V). Median radiation dose is about 0.5 mSv, range between about 0.2 and 1.2 mSv; median contrast agent administration about 45 mL, range between 35 and 55 mL. The experimental intervention is an additional CT scan with a lower dose (about 20 to 50% decrease) and a similar contrast agent administration that is reconstructed with a deep-learning image reconstruction immediately after the clinical CT scan. The additional time required is about 5 minutes.
Signal-to-noise Ratio Low-Dose	17 Ratio Standard Deviation 3
Signal-to-noise Ratio Normal-Dose	16 Ratio Standard Deviation 2

SECONDARY outcome

Timeframe: Day 1

Comparison of dose-length products

Outcome measures

Measure	Normal-dose Versus Low-dose n=50 Participants The standard intervention consists of the routinely performed cardiac CT datasets reconstructed with a standard iterative reconstruction algorithm (ASIR-V). Median radiation dose is about 0.5 mSv, range between about 0.2 and 1.2 mSv; median contrast agent administration about 45 mL, range between 35 and 55 mL. The experimental intervention is an additional CT scan with a lower dose (about 20 to 50% decrease) and a similar contrast agent administration that is reconstructed with a deep-learning image reconstruction immediately after the clinical CT scan. The additional time required is about 5 minutes.
Dose-length Products Low-Dose	31 mGy*cm Interval 25.0 to 34.0
Dose-length Products Normal-Dose	52 mGy*cm Interval 42.0 to 58.0

SECONDARY outcome

Timeframe: Day 1

Quantitative analysis of coronary artery plaque volumes

Outcome measures

Measure	Normal-dose Versus Low-dose n=50 Participants The standard intervention consists of the routinely performed cardiac CT datasets reconstructed with a standard iterative reconstruction algorithm (ASIR-V). Median radiation dose is about 0.5 mSv, range between about 0.2 and 1.2 mSv; median contrast agent administration about 45 mL, range between 35 and 55 mL. The experimental intervention is an additional CT scan with a lower dose (about 20 to 50% decrease) and a similar contrast agent administration that is reconstructed with a deep-learning image reconstruction immediately after the clinical CT scan. The additional time required is about 5 minutes.
Plaque Volumes Low-Dose	12.42 mm^3 Standard Deviation 13.14
Plaque Volumes Normal-Dose	13.84 mm^3 Standard Deviation 14.41

Adverse Events

Low-dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal-dose

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

Dr Ronny R. Buechel

University Hospital Zurich

Phone: +41442551059

Email: ronny.buechel@usz.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place