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

September 15, 2026 updated by: Antonio Esposito, IRCCS San Raffaele

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Coronary artery disease (CAD) is one of the leading causes of morbidity and mortality worldwide. Coronary computed tomography angiography (CCTA) is the first-line imaging test for patients with suspected obstructive CAD. However, its main limitation is the relatively low and variable specificity and positive predictive value across different studies, especially in patients with high calcified coronary plaque burden due to blooming and beam-hardening artifacts that can lead to the overestimation of the degree of coronary artery stenosis, reduced specificity, and, consequently, increased rate of downstream functional imaging tests or diagnostic invasive coronary angiography (ICA). Photon-Counting Detector-Computed Tomography (PCD-CT) represents an important evolution in the CT technology introduced in the clinical practice in the last years, but still with a limited diffusion due to the high purchase cost of the scanners. In the context of CAD evaluation, the two modalities differ in spatial resolution, blooming artifacts, and electronic noise levels, representing distinct technical approaches to diagnostic imaging accuracy. Recent studies demonstrate that these technical advantages may translate into a higher diagnostic accuracy of PCD-CT in differentiating functional significant stenosis from non-significant stenosis, with a lower rate of false positive results and higher overall diagnostic accuracy. This increase in diagnostic accuracy with reduction in false positive results may be associated to a reduction in downstream functional tests performed after a PCD-CT CCTA compared with an EID-CT CCTA, as well as a decrease in unnecessary invasive coronary angiographies resulting from false-positive CCTA findings. Moreover, a more precise diagnosis may also translate into more appropriate treatment decisions and potential prognostic benefits. These potential advantages may ultimately lead to a reduction in downstream healthcare expenditures when using PCD-CT CCTA. However, the impact of these differences on clinical decision-making and healthcare resource utilization remains to be fully established in real-world settings. Thus, the investigator proposes to compare the diagnostic performance of PCD-CT performed with a NAEOTOM Alpha photon-counting CT scanner (Siemens Healthineers, Germany) and EID-CT performed with a SOMATOM Definition Flash (Siemens Healthineers, Germany) in the identification and quantification of CAD. Moreover, the investigator aims to assess the cost-effectiveness and the prognostic impact of PCD-CT compared to EID-CT in CAD diagnosis and management according to 2024 ESC Guidelines, collecting all index data related to the patients' clinical history from the day of the CCTA examination up to two years afterward, and estimating healthcare costs according to the national and regional reimbursement tariffs of the public health system for all healthcare services delivered.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
630

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milano
      • Milan, Milano, Italy, 20132
        • Advanced Imaging for Personalized Medicine/Radiologia DiMer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Energy Integrating Detector CT (EID-CT)

Participants undergo CCTA performed using Energy Integrating Detector CT (EID-CT).
Diagnostic test: Radomization to undergo CCTA with EID-CT

Patients undergoing CCTA on EID-CT
Active Comparator: Photon Counting Detector CT (PCD-CT)

Participants undergo CCTA performed using Photon Counting CT (PCD-CT).
Diagnostic test: Randomization to undergo CCTA with PCD-CT

Undergoing CCTA with PCD-CT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Positive predictive value (PPV) of CCTA for the detection of obstructive CAD, using ICA as the reference standard
Time Frame: 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.
Baseline diagnostic workup

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Up to 3 years after CCTA examination

Incremental cost-effectiveness ratio (ICER), expressed as cost per correctly diagnosed patient based on healthcare resource utilization and diagnostic outcomes. For the calculation of the ICER true negative will be considered all patients with negative CCTA without events (MACEs) over the 3 years FU.
Up to 3 years after CCTA examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COST-PCCT-CCS Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only data used in the results publication will be shared under request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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