Ultra-low-dose CACS in a Large Population

Not Applicable

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Diagnostic Test: Ultra low-dose CTAC

• Registration Number: NCT03637231
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-05
• Study First Submitted: 2018-07-26
• Study First Submitted QC: 2018-08-16
• Study First Posted: 2018-08-17
• Primary Completion: 2021-10-25
• Study Completion: 2021-10-25
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 301

Inclusion Criteria

• Patients referred for a non-contrast enhanced CT scan for CAC scoring
• Male and Female subjects ≥18 years of age,
• Written informed consent

Exclusion Criteria

• Pregnancy or breast-feeding
• CACS of 0 after inclusion of 50 patients with CACS 0 (as assessed visually after the first CT scan, prior to performing the 3 additional study scans)
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Standard and ultra-low-dose CAC scoring	Ultra low-dose CTAC	-

Primary Outcome Measures

Name	Time	Method
Impact of BMI on CAC scores derived from low-dose versus standard-dose CT	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Prognostic value of CAC scores derived from CT scans with varying tube voltages	2 years	Assessment of sensitivity and specificity CAC scores derived from low-dose CT versus standard-dose CT (i.e. standard of reference) to predict future cardiovascular events (i.e. myocardial infarction, revascularisation, death) over a short to mid-term follow-up period (i.e. 2 years).

Trial Locations

Locations (1)

Department of Nuclear Medicine, University Hospital Zurich; 🇨🇭 Zurich, Switzerland