Ultra-low-dose CACS in a Large Population (ULDCACSLARGE)

University of Zurich (UZH)

Status: Terminated

Conditions: Coronary Artery Disease

Treatments: Diagnostic Test: Ultra low-dose CTAC

Study type: Interventional

Funder types: Other

Identifiers

NCT03637231

USZ-2017-01158

Details and patient eligibility

About

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.

Enrollment: 301 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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301 participants in 1 patient group

Standard and ultra-low-dose CAC scoring

Other group

Treatment:

Diagnostic Test: Ultra low-dose CTAC