NCT03637231: ULDCACSLARGE

Ultra-low-dose CACS in a Large Population

Terminated NA Last updated 14 November 2022

What this trial tests

NA trial testing Ultra low-dose CTAC in Coronary Artery Disease in 301 participants. Terminated before completion.

Timeline

5 July 2018

Primary endpoint
25 October 2021

25 October 2021

Quick facts

Lead sponsor	University of Zurich
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	diagnostic
Enrollment	301
Start date	5 July 2018
Primary completion	25 October 2021
Estimated completion	25 October 2021
Sites	1 location across Switzerland

Drugs / interventions tested

• Ultra low-dose CTAC

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

University of Zurich

Who can join

18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Radiation exposure to patients from CT for CAC scoring has steadily decreased in recent years. This is mainly achieved through lowering tube currents alongside with the introduction of iterative reconstruction algorithms which allow compensating for increased image noise. However, the greatest radiation dose reduction can be obtained by reducing peak tube voltage. Yet lowering peak tube voltage remains challenging because tissue attenuation is closely related to photon energy, thus rendering the established thresholds for calculating CAC scores (i.e. Agatston scores) incomparable if peak tube voltages other than the standard 120 kilovolt peak (kVp) are applied. The investigators have developed novel tube-adapted thresholds for CAC scoring by CT at 80 kVp and 70-kVp tube voltage and have shown that these novel thresholds are valid, yielding results closely comparable to the standard 120-kVp protocol. The present study aims to optimize application of such low-dose scans in a general population through assessment of the impact of physiological patient parameters on image parameters such as image noise which per se may impact the accuracy and feasibility of ultra-low-dose CAC scoring with reduced tube voltage. Furthermore, the prognostic performance of such low-dose CAC scoring will be elucidated.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Fully automated deep learning powered calcium scoring in patients undergoing myocardial perfusion imaging.
   Sartoretti T, Gennari AG, Sartoretti E, Skawran S, et al · · 2023 · cited 12× · PMID 35301677 · DOI 10.1007/s12350-022-02940-7
2. Risk stratification using coronary artery calcium scoring based on low tube voltage computed tomography.
   Bechtiger FA, Grossmann M, Bakula A, Patriki D, et al · · 2022 · cited 4× · PMID 37726457 · DOI 10.1007/s10554-022-02615-x