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

Study acronym: COST-PCCT-CCS
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07831304
Lead Sponsor IRCCS San Raffaele
Conditions Computed Tomography Angiography, Coronary Artery Disease
Enrollment 630 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov