N/A
N=50
Deep-Learning Image Reconstruction in CCTA
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT03980470 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Subjective Image Quality — 5; 5 Score on a Likert scale (0-5) 5=best
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TrueFidelity (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Zurich
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Image Quality |
5; 5 | — |
| SECONDARY Signal Intensity |
462; 443 | 0.198 |
| SECONDARY Image Noise |
27; 28 | 0.9 |
| SECONDARY Signal-to-noise Ratio |
17; 16 | 0.8 |
| SECONDARY Dose-length Products |
31; 52 | <0.001 sig |
| SECONDARY Plaque Volumes |
12.42; 13.84 | — |
Summary
Cardiac CT allows the assessment of the heart and of the coronary arteries by use of ionising radiation. Although radiation exposure was significantly reduced in recent years, further decrease in radiation exposure is limited by increased image noise and deterioration in image quality. Recent evidence suggests that further technological refinements with artificial intelligence allows improved post-processing of images with reduction of image noise.
The present study aims at assessing the potential of a deep-learning image reconstruction algorithm in a clinical setting. Specifically, after a standard clinical scan, patients are scanned with lower radiation exposure and reconstructed with the DLIR algorithm. This interventional scan is then compared to the standard clinical scan.
Eligibility Criteria
Inclusion Criteria
- Patients referred for cardiac CT angiography
- Age ≥ 18 years
- Written informed consent
Exclusion Criteria
- Pregnancy or breast-feeding
- Enrollment of the investigator, his/her family members, employees and other dependent persons
- Renal insufficiency (GFR below 35 mL/min/1.73 m²)
Data sourced from ClinicalTrials.gov (NCT03980470). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.