Randomized Prospective Trial on the Cost-Effectiveness of Photon-Counting CT Versus Energy-Integrating Detector CT in Suspected Chronic Coronary Syndrome

Condition(s) studied

Investigational drug(s) / intervention(s)

Radomization to undergo CCTA with EID-CT: Patients undergoing CCTA on EID-CT

Randomization to undergo CCTA with PCD-CT: Undergoing CCTA with PCD-CT

Study summary

Coronary artery disease (CAD) is a leading cause of morbidity and mortality worldwide. Coronary computed tomography angiography (CCTA) is recommended as a first-line imaging test in patients with suspected obstructive CAD. However, conventional energy-integrating detector CT (EID-CT) has limited specificity, particularly in patients with a high coronary calcification burden, because blooming and beam-hardening artifacts can lead to stenosis overestimation and potentially unnecessary downstream diagnostic testing or invasive coronary angiography (ICA). Photon-counting detector CT (PCD-CT) provides higher spatial resolution, reduced electronic noise, and decreased blooming artifacts compared with conventional EID-CT. These technical advantages may improve the diagnostic assessment of coronary stenoses, reduce false-positive findings, and consequently decrease the need for additional functional testing and unnecessary ICA. Improved diagnostic accuracy may also influence treatment decisions, patient outcomes, and healthcare resource utilization.

This study aims to compare PCD-CT and EID-CT CCTA for the detection and quantification of CAD in a real-world clinical setting. In addition to diagnostic performance, the study will evaluate the impact of the two imaging strategies on subsequent diagnostic and therapeutic management, healthcare resource utilization, costs, and clinical outcomes. Patients will be followed from the date of the index CCTA examination for up to two years. Healthcare costs will be estimated using national and regional reimbursement tariffs of the Italian public healthcare system.

Eligibility

Primary outcome measure(s)

• Positive predictive value (PPV) of CCTA for the detection of obstructive CAD, using ICA as the reference standard — Baseline diagnostic workup
  To compare the positive predictive value (PPV) of coronary computed tomography angiography (CCTA) performed using PCD-CT versus EID-CT, when used according to the clinical indications defined by the 2024 ESC Guidelines for the management of chronic coronary syndromes.

Trial sites (1)

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