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

NCT07831304 | Active Not Recruiting

• 1 other identifier: COST-PCCT-CCS Trial
• Study Type: interventional
• Target: 630
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Computed Tomography Angiography; Coronary Artery Disease

Keywords

Photon Counting CT; CAD; Diagnosis; Prognosis; Ischemic Heart Disease; Chronic Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• Positive predictive value (PPV) of CCTA for the detection of obstructive CAD, using ICA as the reference standard

  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.

  Baseline diagnostic workup

Secondary Outcomes (1)

• To evaluate the cost effectiveness comparing two CT platforms implemented in routine clinical practice in the diagnostic workup of suspected chronic coronary syndromes, according to the 2024 ESC Guidelines.

  Up to 3 years after CCTA examination

Study Arms (2)

Energy Integrating Detector CT (EID-CT)

ACTIVE COMPARATOR

Participants undergo CCTA performed using Energy Integrating Detector CT (EID-CT).

Diagnostic Test: Radomization to undergo CCTA with EID-CT

Photon Counting Detector CT (PCD-CT)

ACTIVE COMPARATOR

Participants undergo CCTA performed using Photon Counting CT (PCD-CT).

Diagnostic Test: Randomization to undergo CCTA with PCD-CT

Interventions

Radomization to undergo CCTA with EID-CT DIAGNOSTIC_TEST

Patients undergoing CCTA on EID-CT

Energy Integrating Detector CT (EID-CT)

Randomization to undergo CCTA with PCD-CT DIAGNOSTIC_TEST

Undergoing CCTA with PCD-CT

Photon Counting Detector CT (PCD-CT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical indication to perform CCTA for CAD assessment according to 2024 ESC Guidelines

You may not qualify if:

• Refusal to participate in the study
• Age \<18 years old
• Severe reduction in eGFR (\<30 mL/min)

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Advanced Imaging for Personalized Medicine/Radiologia DiMer

Milan, Milano, 20132, Italy

Location

Related Publications (16)

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MeSH Terms

Conditions

Coronary Artery Disease; Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Radiology

Model Details: 2 randomized group (EID-CT vs PCD-CT)

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 21, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2029
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)