Study Stopped
The preliminary findings render it very unlikely that the methodology can be refined further in order to yield more accurate results even if more patients would be included and the study would be continued.
Ultra-low-dose CACS in a Large Population
ULDCACSLARGE
Ultra-low-dose Coronary Artery Calcium Scoring: Evaluation of Prognostic Performance and Impact of Physiological Factors on Quantification in a Large Population
1 other identifier
interventional
301
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Jul 2018
Typical duration for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 5, 2018
CompletedFirst Submitted
Initial submission to the registry
July 26, 2018
CompletedFirst Posted
Study publicly available on registry
August 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2021
CompletedNovember 14, 2022
November 1, 2022
3.3 years
July 26, 2018
November 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Impact of BMI on CAC scores derived from low-dose versus standard-dose CT
Assessment of deviation of CAC scores derived from low-dose CT versus standard-dose CT (i.e. standard of reference) by calculating bias and Bland-Altmann limits of agreement as well as intraclass correlation in different subgroups of patients, stratified by body mass index.
2 years
Secondary Outcomes (1)
Prognostic value of CAC scores derived from CT scans with varying tube voltages
2 years
Study Arms (1)
Standard and ultra-low-dose CAC scoring
OTHERInterventions
All patients undergo two non-contrast enhanced CT scans with standard dose (i.e. 120 kVp), one with 80 kVp and one with 70 kVp.
Eligibility Criteria
You may qualify if:
- Patients referred for a non-contrast enhanced CT scan for CAC scoring
- Male and Female subjects ≥18 years of age,
- Written informed consent
You may not qualify if:
- Pregnancy or breast-feeding
- History of coronary artery stenting, coronary artery bypass grafting, of implantation of cardiac devices (e.g. valve prosthesis, pacemaker, implantable cardioverter defibrillator etc.)
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Nuclear Medicine, University Hospital Zurich
Zurich, 8091, Switzerland
Related Publications (3)
Grani C, Vontobel J, Benz DC, Bacanovic S, Giannopoulos AA, Messerli M, Grossmann M, Gebhard C, Pazhenkottil AP, Gaemperli O, Kaufmann PA, Buechel RR. Ultra-low-dose coronary artery calcium scoring using novel scoring thresholds for low tube voltage protocols-a pilot study. Eur Heart J Cardiovasc Imaging. 2018 Dec 1;19(12):1362-1371. doi: 10.1093/ehjci/jey019.
PMID: 29432592BACKGROUNDBechtiger FA, Grossmann M, Bakula A, Patriki D, von Felten E, Fuchs TA, Gebhard C, Pazhenkottil AP, Kaufmann PA, Buechel RR. Risk stratification using coronary artery calcium scoring based on low tube voltage computed tomography. Int J Cardiovasc Imaging. 2022 Oct;38(10):2227-2234. doi: 10.1007/s10554-022-02615-x. Epub 2022 Apr 23.
PMID: 37726457DERIVEDSartoretti T, Gennari AG, Sartoretti E, Skawran S, Maurer A, Buechel RR, Messerli M. Fully automated deep learning powered calcium scoring in patients undergoing myocardial perfusion imaging. J Nucl Cardiol. 2023 Feb;30(1):313-320. doi: 10.1007/s12350-022-02940-7. Epub 2022 Mar 17.
PMID: 35301677DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2018
First Posted
August 17, 2018
Study Start
July 5, 2018
Primary Completion
October 25, 2021
Study Completion
October 25, 2021
Last Updated
November 14, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share