Computed Tomography AngiographyCOST-PCCT-CCSNCT07831304
Randomized Prospective Trial on the Cost-Effectiveness of Photon-Counting CT Versus Energy-Integrating Detector CT in Suspected Chronic Coronary Syndrome
A study testing Radomization to undergo CCTA with EID-CT and Randomization to undergo CCTA with PCD-CT in people with Computed Tomography Angiography and Coronary Artery Disease, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Computed Tomography Angiography, Coronary Artery Disease
- What is being tested?
- Radomization to undergo CCTA with EID-CT and Randomization to undergo CCTA with PCD-CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical indication to perform CCTA for CAD assessment according to 2024 ESC Guidelines
Who cannot join
- Refusal to participate in the study
- Age <18 years old
- Severe reduction in eGFR (<30 mL/min)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Advanced Imaging for Personalized Medicine/Radiologia DiMer
Milan, Milano, 20132
Anna Ferrari, Ms, +3902-26432643, ferrari.anna@hsr.it
About this study
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.
Read the 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.
- Being tested
- Radomization to undergo CCTA with EID-CT, Randomization to undergo CCTA with PCD-CT
- Keywords
- Photon Counting CT, CAD, Diagnosis, Prognosis, Ischemic Heart Disease, Chronic Coronary Syndrome
- Medical subject headings
- Coronary Artery Disease, Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radomization to undergo CCTA with EID-CTDiagnostic test
Patients undergoing CCTA on EID-CT
Randomization to undergo CCTA with PCD-CTDiagnostic test
Undergoing CCTA with PCD-CT
| Study group | Role | What they receive |
|---|---|---|
| Energy Integrating Detector CT (EID-CT) | Active comparator | Participants undergo CCTA performed using Energy Integrating Detector CT (EID-CT). Receives: 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). Receives: Diagnostic Test: Randomization to undergo CCTA with PCD-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Up to 3 years after CCTA examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Sep 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Computed Tomography AngiographyStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 randomized group (EID-CT vs PCD-CT)
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Esposito, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831304
- Sponsor's protocol ID
- COST-PCCT-CCS Trial
- Acronym
- COST-PCCT-CCS
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only data used in the results publication will be shared under request
Publications
Brix MAK, Okkonen M, Makela T, Nikki M, Korhonen M, Nieminen MT. Cost-effectiveness of photon counting detector CT for coronary artery disease diagnostics: A Finnish healthcare perspective. Eur J Radiol. 2025 Sep;190:112245. doi: 10.1016/j.ejrad.2025.112245. Epub 2025 Jun 16.
PubMed 40540955Vecsey-Nagy M, Emrich T, Tremamunno G, Kravchenko D, Taha Hagar M, Laux GS, Schoepf UJ, O'Doherty J, Boussoussou M, Szilveszter B, Maurovich-Horvat P, Kroencke T, Kabakus IM, Spruill Suranyi P, Varga-Szemes A, Decker JA. Cost-effectiveness of ultrahigh-resolution photon-counting detector coronary CT angiography for the evaluation of stable chest pain. J Cardiovasc Comput Tomogr. 2025 Jan-Feb;19(1):106-112. doi: 10.1016/j.jcct.2024.10.011. Epub 2024 Nov 4.
PubMed 39500702Sakai K, Shin D, Singh M, Malik S, Dakroub A, Sami Z, Weber J, Cao JJ, Parikh R, Chen L, Sosa F, Cohen DJ, Moses JW, Shlofmitz RA, Collet C, Shlofmitz E, Jeremias A, Khalique OK, Ali ZA. Diagnostic Performance and Clinical Impact of Photon-Counting Detector Computed Tomography in Coronary Artery Disease. J Am Coll Cardiol. 2025 Feb 4;85(4):339-348. doi: 10.1016/j.jacc.2024.10.069. Epub 2024 Oct 28.
PubMed 39466216Koons E, VanMeter P, Rajendran K, Yu L, McCollough C, Leng S. Improved quantification of coronary artery luminal stenosis in the presence of heavy calcifications using photon-counting detector CT. Proc SPIE Int Soc Opt Eng. 2022 Feb-Mar;12031:120311A. doi: 10.1117/12.2613019. Epub 2022 Apr 4.
PubMed 35677467Si-Mohamed SA, Boccalini S, Lacombe H, Diaw A, Varasteh M, Rodesch PA, Dessouky R, Villien M, Tatard-Leitman V, Bochaton T, Coulon P, Yagil Y, Lahoud E, Erhard K, Riche B, Bonnefoy E, Rioufol G, Finet G, Bergerot C, Boussel L, Greffier J, Douek PC. Coronary CT Angiography with Photon-counting CT: First-In-Human Results. Radiology. 2022 May;303(2):303-313. doi: 10.1148/radiol.211780. Epub 2022 Feb 15.
PubMed 35166583Bluemke DA, Lima JAC. Cardiac Imaging 2040. Radiology. 2023 May;307(3):e230160. doi: 10.1148/radiol.230160. Epub 2023 Apr 11. No abstract available.
PubMed 37039692Kiani I, Mohebbi A, Jannatdoust P, Darmiani K, Mohammadzdeh S, Mohammadi A, Gholamrezanezhead A. Comparison of photon-counting CT angiography with energy-integrating CT angiography in coronary artery stenosis: a systematic review and meta-analysis. BMC Med Imaging. 2025 Nov 28;25(1):496. doi: 10.1186/s12880-025-02038-9.
PubMed 41315979Esquivel A, Ferrero A, Mileto A, Baffour F, Horst K, Rajiah PS, Inoue A, Leng S, McCollough C, Fletcher JG. Photon-Counting Detector CT: Key Points Radiologists Should Know. Korean J Radiol. 2022 Sep;23(9):854-865. doi: 10.3348/kjr.2022.0377.
PubMed 36047540Celeng C, Leiner T, Maurovich-Horvat P, Merkely B, de Jong P, Dankbaar JW, van Es HW, Ghoshhajra BB, Hoffmann U, Takx RAP. Anatomical and Functional Computed Tomography for Diagnosing Hemodynamically Significant Coronary Artery Disease: A Meta-Analysis. JACC Cardiovasc Imaging. 2019 Jul;12(7 Pt 2):1316-1325. doi: 10.1016/j.jcmg.2018.07.022. Epub 2018 Sep 12.
PubMed 30219398Simon J, Hrenko A, Kerkovits NM, Nagy K, Vertes M, Balogh H, Nagy N, Munkacsi T, Emrich T, Varga-Szemes A, Boussoussou M, Vattay B, Vecsey-Nagy M, Kolossvary M, Szilveszter B, Merkely B, Maurovich-Horvat P. Photon-counting detector CT reduces the rate of referrals to invasive coronary angiography as compared to CT with whole heart coverage energy-integrating detector. J Cardiovasc Comput Tomogr. 2024 Jan-Feb;18(1):69-74. doi: 10.1016/j.jcct.2023.11.079. Epub 2023 Dec 13.
PubMed 38097408Kalisz K, Buethe J, Saboo SS, Abbara S, Halliburton S, Rajiah P. Artifacts at Cardiac CT: Physics and Solutions. Radiographics. 2016 Nov-Dec;36(7):2064-2083. doi: 10.1148/rg.2016160079. Epub 2016 Oct 21.
PubMed 27768543Boussoussou M, Vattay B, Szilveszter B, et al. Functional assessment of coronary plaques using CT based hemodynamic simulations: current status, technical principles and clinical value. Imaging. 2021;13(1):37-48. https://doi.org/10.1556/ 1647.2020.00011.
Knuuti J, Ballo H, Juarez-Orozco LE, Saraste A, Kolh P, Rutjes AWS, Juni P, Windecker S, Bax JJ, Wijns W. The performance of non-invasive tests to rule-in and rule-out significant coronary artery stenosis in patients with stable angina: a meta-analysis focused on post-test disease probability. Eur Heart J. 2018 Sep 14;39(35):3322-3330. doi: 10.1093/eurheartj/ehy267.
PubMed 29850808Esposito A, Francone M, Andreini D, Buffa V, Cademartiri F, Carbone I, Clemente A, Guaricci AI, Guglielmo M, Indolfi C, La Grutta L, Ligabue G, Liguori C, Mercuro G, Mushtaq S, Neglia D, Palmisano A, Sciagra R, Seitun S, Vignale D, Pontone G, Carrabba N. SIRM-SIC appropriateness criteria for the use of Cardiac Computed Tomography. Part 1: Congenital heart diseases, primary prevention, risk assessment before surgery, suspected CAD in symptomatic patients, plaque and epicardial adipose tissue characterization, and functional assessment of stenosis. Radiol Med. 2021 Sep;126(9):1236-1248. doi: 10.1007/s11547-021-01378-0. Epub 2021 Jun 23.
PubMed 34160775Virani SS, Newby LK, Arnold SV, Bittner V, Brewer LC, Demeter SH, Dixon DL, Fearon WF, Hess B, Johnson HM, Kazi DS, Kolte D, Kumbhani DJ, LoFaso J, Mahtta D, Mark DB, Minissian M, Navar AM, Patel AR, Piano MR, Rodriguez F, Talbot AW, Taqueti VR, Thomas RJ, van Diepen S, Wiggins B, Williams MS; Peer Review Committee Members. 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. 2023 Aug 29;148(9):e9-e119. doi: 10.1161/CIR.0000000000001168. Epub 2023 Jul 20.
PubMed 37471501
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Trial on the Cost-Effectiveness of Photon-Counting CT Versus Energy-Integrating Detector CT in Suspected Chronic Coronary Syndrome
- ClinicalTrials.gov ID
- NCT07831304
- Acronym / sponsor ID
- COST-PCCT-CCS / COST-PCCT-CCS Trial
- Keywords
- Photon Counting CT, CAD, Diagnosis, Prognosis, Ischemic Heart Disease, Chronic Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- 2 randomized group (EID-CT vs PCD-CT)
| Arm | Type | Receives |
|---|---|---|
| Energy Integrating Detector CT (EID-CT) | Active comparator | Diagnostic Test: Radomization to undergo CCTA with EID-CTParticipants undergo CCTA performed using Energy Integrating Detector CT (EID-CT). |
| Photon Counting Detector CT (PCD-CT) | Active comparator | Diagnostic Test: Randomization to undergo CCTA with PCD-CTParticipants undergo CCTA performed using Photon Counting CT (PCD-CT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical indication to perform CCTA for CAD assessment according to 2024 ESC Guidelines
Key exclusion criteria (3 listed)
- Refusal to participate in the study
- Age <18 years old
- Severe reduction in eGFR (<30 mL/min)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radomization to undergo CCTA with EID-CTPatients undergoing CCTA on EID-CT | Diagnostic test | Energy Integrating Detector CT (EID-CT) |
| Randomization to undergo CCTA with PCD-CTUndergoing CCTA with PCD-CT | Diagnostic test | Photon Counting Detector CT (PCD-CT) |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 40540955Brix MAK, Okkonen M, Makela T, Nikki M, Korhonen M, Nieminen MT. Cost-effectiveness of photon counting detector CT for coronary artery disease diagnostics: A Finnish healthcare perspective. Eur J Radiol. 2025 Sep;190:112245. doi: 10.1016/j.ejrad.2025.112245. Epub 2025 Jun 16.
- Background: PubMed 39500702Vecsey-Nagy M, Emrich T, Tremamunno G, Kravchenko D, Taha Hagar M, Laux GS, Schoepf UJ, O'Doherty J, Boussoussou M, Szilveszter B, Maurovich-Horvat P, Kroencke T, Kabakus IM, Spruill Suranyi P, Varga-Szemes A, Decker JA. Cost-effectiveness of ultrahigh-resolution photon-counting detector coronary CT angiography for the evaluation of stable chest pain. J Cardiovasc Comput Tomogr. 2025 Jan-Feb;19(1):106-112. doi: 10.1016/j.jcct.2024.10.011. Epub 2024 Nov 4.
- Background: PubMed 39466216Sakai K, Shin D, Singh M, Malik S, Dakroub A, Sami Z, Weber J, Cao JJ, Parikh R, Chen L, Sosa F, Cohen DJ, Moses JW, Shlofmitz RA, Collet C, Shlofmitz E, Jeremias A, Khalique OK, Ali ZA. Diagnostic Performance and Clinical Impact of Photon-Counting Detector Computed Tomography in Coronary Artery Disease. J Am Coll Cardiol. 2025 Feb 4;85(4):339-348. doi: 10.1016/j.jacc.2024.10.069. Epub 2024 Oct 28.
- Background: PubMed 35677467Koons E, VanMeter P, Rajendran K, Yu L, McCollough C, Leng S. Improved quantification of coronary artery luminal stenosis in the presence of heavy calcifications using photon-counting detector CT. Proc SPIE Int Soc Opt Eng. 2022 Feb-Mar;12031:120311A. doi: 10.1117/12.2613019. Epub 2022 Apr 4.
- Background: PubMed 35166583Si-Mohamed SA, Boccalini S, Lacombe H, Diaw A, Varasteh M, Rodesch PA, Dessouky R, Villien M, Tatard-Leitman V, Bochaton T, Coulon P, Yagil Y, Lahoud E, Erhard K, Riche B, Bonnefoy E, Rioufol G, Finet G, Bergerot C, Boussel L, Greffier J, Douek PC. Coronary CT Angiography with Photon-counting CT: First-In-Human Results. Radiology. 2022 May;303(2):303-313. doi: 10.1148/radiol.211780. Epub 2022 Feb 15.
- Background: PubMed 37039692Bluemke DA, Lima JAC. Cardiac Imaging 2040. Radiology. 2023 May;307(3):e230160. doi: 10.1148/radiol.230160. Epub 2023 Apr 11. No abstract available.
- Background: PubMed 41315979Kiani I, Mohebbi A, Jannatdoust P, Darmiani K, Mohammadzdeh S, Mohammadi A, Gholamrezanezhead A. Comparison of photon-counting CT angiography with energy-integrating CT angiography in coronary artery stenosis: a systematic review and meta-analysis. BMC Med Imaging. 2025 Nov 28;25(1):496. doi: 10.1186/s12880-025-02038-9.
- Background: PubMed 36047540Esquivel A, Ferrero A, Mileto A, Baffour F, Horst K, Rajiah PS, Inoue A, Leng S, McCollough C, Fletcher JG. Photon-Counting Detector CT: Key Points Radiologists Should Know. Korean J Radiol. 2022 Sep;23(9):854-865. doi: 10.3348/kjr.2022.0377.
- Background: PubMed 30219398Celeng C, Leiner T, Maurovich-Horvat P, Merkely B, de Jong P, Dankbaar JW, van Es HW, Ghoshhajra BB, Hoffmann U, Takx RAP. Anatomical and Functional Computed Tomography for Diagnosing Hemodynamically Significant Coronary Artery Disease: A Meta-Analysis. JACC Cardiovasc Imaging. 2019 Jul;12(7 Pt 2):1316-1325. doi: 10.1016/j.jcmg.2018.07.022. Epub 2018 Sep 12.
- Background: PubMed 38097408Simon J, Hrenko A, Kerkovits NM, Nagy K, Vertes M, Balogh H, Nagy N, Munkacsi T, Emrich T, Varga-Szemes A, Boussoussou M, Vattay B, Vecsey-Nagy M, Kolossvary M, Szilveszter B, Merkely B, Maurovich-Horvat P. Photon-counting detector CT reduces the rate of referrals to invasive coronary angiography as compared to CT with whole heart coverage energy-integrating detector. J Cardiovasc Comput Tomogr. 2024 Jan-Feb;18(1):69-74. doi: 10.1016/j.jcct.2023.11.079. Epub 2023 Dec 13.
- Background: PubMed 27768543Kalisz K, Buethe J, Saboo SS, Abbara S, Halliburton S, Rajiah P. Artifacts at Cardiac CT: Physics and Solutions. Radiographics. 2016 Nov-Dec;36(7):2064-2083. doi: 10.1148/rg.2016160079. Epub 2016 Oct 21.
- BackgroundBoussoussou M, Vattay B, Szilveszter B, et al. Functional assessment of coronary plaques using CT based hemodynamic simulations: current status, technical principles and clinical value. Imaging. 2021;13(1):37-48. https://doi.org/10.1556/ 1647.2020.00011.
- Individual participant dataSharing planned: No. Only data used in the results publication will be shared under request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radomization to undergo CCTA with EID-CT and Randomization to undergo CCTA with PCD-CT in people with Computed Tomography Angiography and Coronary Artery Disease, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Esposito, prof. Dr. (+39 02-26432643, esposito.antonio@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive predictive value (PPV) of CCTA for the detection of obstructive CAD, using ICA as the reference standard (time frame: Baseline diagnostic workup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07831304, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.