An interventional study of Radomization to undergo CCTA with EID-CT and Randomization to undergo CCTA with PCD-CT in Computed Tomography Angiography and Coronary Artery Disease, sponsored by IRCCS San Raffaele. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by IRCCS San Raffaele · Not applicable, Interventional, and Diagnostic
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.
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 630 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →IRCCS San Raffaele is the lead sponsor of 453 studies on the registry; 234 are open to participants now.
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Exclusion Criteria:
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GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergo CCTA performed using Energy Integrating Detector CT (EID-CT).
Diagnostic Test: Radomization to undergo CCTA with EID-CT
Participants undergo CCTA performed using Photon Counting CT (PCD-CT).
Diagnostic Test: Randomization to undergo CCTA with PCD-CT
Patients undergoing CCTA on EID-CT
Undergoing CCTA with PCD-CT
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.
Time frame: Baseline diagnostic workup
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.
Time frame: Up to 3 years after CCTA examination
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Only data used in the results publication will be shared under request
Started Sep 2026 (actual). Primary completion is estimated for Sep 2027, 12 months after the start.
Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 12 months is below that.
Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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