Coronary Artery DiseaseSILIC-HEARTNCT07411196
Silicon-based Photon Counting Computed Tomography for Advanced Cardiac Imaging
A study testing Photon-counting computed tomography in people with Coronary Artery Disease, run by Ronny R Buechel, MD.
Trial summary
Computed tomography (CT) is a key imaging modality, with rapidly increasing use in cardiovascular diagnostics. Coronary CT angiography (CCTA) provides high-resolution, non-invasive assessment of coronary anatomy and is now recommended as a first-line test for suspected coronary artery disease (CAD) due to its… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Photon-counting computed tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 30 Apr 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
- Referred for clinically indicated cardiac CT
- Age ≥18 years
- Informed Consent signed by the subject
Who cannot join
- Known allergy to iodinated contrast
- Pregnancy
- Impaired renal function (eGFR<30ml/min/1.73m2)
- Any other common contraindication for routine cardiac CT or any other reason leading to the inability to successfully and completely perform routine cardiac CT with and without contrast-enhancement
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Computed tomography (CT) is a key imaging modality, with rapidly increasing use in cardiovascular diagnostics. Coronary CT angiography (CCTA) provides high-resolution, non-invasive assessment of coronary anatomy and is now recommended as a first-line test for suspected coronary artery disease (CAD) due to its excellent sensitivity, allowing for the firm exclusion of the disease. CCTA, accompanied by coronary artery calcium (CAC) scanning have become, therefore, recommended as the first-line diagnostic modalities in a majority of patients with suspected CAD. It is thanks to the steady efforts to improve this modality's diagnostic performance further and reduce patients' exposure to radiation and contrast agents that have contributed to the successful implementation of this modality in routine clinical practice. However, further progress with conventional energy-integrating detector (EID) CT is limited by detector physics, as EIDs measure only total deposited x-ray energy.
By contrast, photon-counting CT (PCCT) introduces semiconductor detectors that register individual photons and their energies, enabling higher spatial resolution, improved contrast-to-noise, and intrinsic spectral imaging. Early PCCT systems have shown better visualization of small coronary structures and reduced blooming, though limitations such as degraded energy resolution at high speeds and cross-talk still restrict full spectral performance. Radiation dose reductions are possible but have not yet been consistently achieved compared with optimized EID-CCTA, which is critical if PCCT is to be used for risk stratification or screening. There remains a need to better exploit PCCT's spectral capabilities for plaque and stent evaluation while maintaining acceptable radiation and contrast exposure. By 2026, second-generation silicon-based scanners (Si-PCCT) are approaching, offering potential improvements over first-generation cadmium-telluride systems. The present study aims to evaluate the diagnostic performance of such devices and exploit their technical advantages to lower radiation dose.
Read the detailed description
Cardiovascular disease remains one of the leading causes of morbidity and mortality worldwide and represents a major burden for healthcare systems. In patients with suspected or known coronary artery disease (CAD), coronary CT angiography (CCTA) has become a cornerstone of contemporary clinical practice, owing to its high sensitivity, excellent negative predictive value, and non-invasive character. Current guidelines recommend CCTA as a first-line diagnostic test in a broad range of patients with suspected CAD, reflecting its established role in everyday cardiology (Eur Heart J. 2024 Sep 29;45(36):3415-537).
Despite continuous technical refinement, conventional CT systems based on energy-integrating detectors (EID-CT) have inherent physical limitations. These include suboptimal spatial resolution for small coronary structures, blooming artefacts in calcified plaques and stents, limited spectral information, and trade-offs between image quality and radiation and contrast dose. While state-of-the-art EID-CT can achieve very low radiation doses, further meaningful improvements in image fidelity and tissue characterization are increasingly constrained by detector physics (Diagn Interv Imaging. 2025 Feb;106(2):53-9).
Photon-counting CT (PCCT) represents a fundamental technological advance by enabling direct photon detection with intrinsic energy discrimination. Early, first-generation PCCT systems have demonstrated improved spatial resolution, reduced blooming artefacts, and the feasibility of spectral CCTA, with encouraging results for plaque assessment and coronary stenosis evaluation. However, published clinical studies have also highlighted relevant limitations, including compromised energy resolution during fast cardiac acquisitions, cross-talk effects, and radiation doses that often remain higher than those achieved with optimized EID-CT protocols. As a result, the full clinical potential of PCCT-particularly for low-dose cardiovascular imaging and quantitative plaque characterization-has not yet been realized, and robust evidence supporting broad clinical adoption is still lacking (J Cardiovasc Comput Tomogr. 2025 Jul-Aug;19(4):474-82).
A second generation of PCCT scanners based on silicon detectors (Si-PCCT) has recently been developed to overcome these limitations (Phys Med Biol.2021 Jan 29;66(3):03tr1). The physical properties of silicon detectors, combined with an edge-on detector geometry and depth-segmented pixels, provide superior count-rate capability, improved energy separation, and high spatial resolution. Preliminary phantom studies and early prototype investigations suggest that Si-PCCT may enable high-quality coronary imaging at substantially reduced radiation and contrast doses while offering reliable spectral information for advanced plaque analysis (Radiology. 2024 Jun;311(3):e231598). However, systematic clinical evidence in humans is currently sparse, particularly in the setting of cardiovascular imaging that requires fast acquisition and high temporal resolution.
The present clinical investigation addresses this critical knowledge gap. Its primary purpose is to evaluate the diagnostic performance, dose efficiency, and clinical feasibility of Si-PCCT for CCTA in direct comparison with established EID-CT and, where available, invasive coronary angiography. By prospectively evaluating low-dose acquisition protocols, comparing quantitative plaque burden and composition, and exploring the impact on diagnostic accuracy and functional assessment, this study aims to establish whether Si-PCCT can deliver clinically meaningful improvements beyond the current state of the art. The results are expected to provide essential evidence to guide safe clinical implementation of Si-PCCT and to inform future applications in cardiovascular risk stratification, prevention, and patient management.
- Conditions
- Coronary Artery Disease
- Being tested
- Photon-counting computed tomography
- Keywords
- coronary artery disease, photon-counting computed tomography, coronary computed tomography angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photon-counting computed tomographyDevice
Device is a novel second generation photon-counting CT device with silicon-based detectors
| Study group | Role | What they receive |
|---|---|---|
| Patients underdoing clinically indicated coronary CT angiography | Other | All participants will undergo both clinically indicated coronary CT on a conventional CT scanner plus additional coronary CT on the photon-counting CT scanner Receives: Device: Photon-counting computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality of standard and low-dose Si-PCCT CCTA acquisition protocols versus the standard-of-care EID-CT CCTA protocol.
Proportion of patients with ≥95% interpretable coronary segments achieved with standard and low-dose Si-PCCT protocols vs. the reference protocols.
Measured: Same day as enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Photon-counting computed tomography device with silicon-based detectors
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ronny R Buechel, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ronny R Buechel, MD, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411196
- Sponsor's protocol ID
- SILIC-HEART
- Acronym
- SILIC-HEART
- Status last verified
- Sep 2026
- First submitted
- 3 Feb 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silicon-based Photon Counting Computed Tomography for Advanced Cardiac Imaging
- ClinicalTrials.gov ID
- NCT07411196
- Acronym / sponsor ID
- SILIC-HEART / SILIC-HEART
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, photon-counting computed tomography, coronary computed tomography angiography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ronny R Buechel, MDUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 13 Feb 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.
Computed tomography (CT) is a key imaging modality, with rapidly increasing use in cardiovascular diagnostics. Coronary CT angiography (CCTA) provides high-resolution, non-invasive assessment of coronary anatomy and is now recommended as a first-line test for suspected coronary artery disease (CAD) due to its excellent sensitivity, allowing for the firm exclusion of the disease. CCTA, accompanied by coronary artery calcium (CAC) scanning have become, therefore, recommended as the first-line diagnostic modalities in a majority of patients with suspected CAD. It is thanks to the steady efforts to improve this modality's diagnostic performance further and reduce patients' exposure to radiation and contrast agents that have contributed to the successful implementation of this modality in routine clinical practice. However, further progress with conventional energy-integrating detector (EID) CT is limited by detector physics, as EIDs measure only total deposited x-ray energy.
By contrast, photon-counting CT (PCCT) introduces semiconductor detectors that register individual photons and their energies, enabling higher spatial resolution, improved contrast-to-noise, and intrinsic spectral imaging. Early PCCT systems have shown better visualization of small coronary structures and reduced blooming, though limitations such as degraded energy resolution at high speeds and cross-talk still restrict full spectral performance. Radiation dose reductions are possible but have not yet been consistently achieved compared with optimized EID-CCTA, which is critical if PCCT is to be used for risk stratification or screening. There remains a need to better exploit PCCT's spectral capabilities for plaque and stent evaluation while maintaining acceptable radiation and contrast exposure. By 2026, second-generation silicon-based scanners (Si-PCCT) are approaching, offering potential improvements over first-generation cadmium-telluride systems. The present study aims to evaluate the diagnostic performance of such devices and exploit their technical advantages to lower radiation dose.
Detailed description
Cardiovascular disease remains one of the leading causes of morbidity and mortality worldwide and represents a major burden for healthcare systems. In patients with suspected or known coronary artery disease (CAD), coronary CT angiography (CCTA) has become a cornerstone of contemporary clinical practice, owing to its high sensitivity, excellent negative predictive value, and non-invasive character. Current guidelines recommend CCTA as a first-line diagnostic test in a broad range of patients with suspected CAD, reflecting its established role in everyday cardiology (Eur Heart J. 2024 Sep 29;45(36):3415-537).
Despite continuous technical refinement, conventional CT systems based on energy-integrating detectors (EID-CT) have inherent physical limitations. These include suboptimal spatial resolution for small coronary structures, blooming artefacts in calcified plaques and stents, limited spectral information, and trade-offs between image quality and radiation and contrast dose. While state-of-the-art EID-CT can achieve very low radiation doses, further meaningful improvements in image fidelity and tissue characterization are increasingly constrained by detector physics (Diagn Interv Imaging. 2025 Feb;106(2):53-9).
Photon-counting CT (PCCT) represents a fundamental technological advance by enabling direct photon detection with intrinsic energy discrimination. Early, first-generation PCCT systems have demonstrated improved spatial resolution, reduced blooming artefacts, and the feasibility of spectral CCTA, with encouraging results for plaque assessment and coronary stenosis evaluation. However, published clinical studies have also highlighted relevant limitations, including compromised energy resolution during fast cardiac acquisitions, cross-talk effects, and radiation doses that often remain higher than those achieved with optimized EID-CT protocols. As a result, the full clinical potential of PCCT-particularly for low-dose cardiovascular imaging and quantitative plaque characterization-has not yet been realized, and robust evidence supporting broad clinical adoption is still lacking (J Cardiovasc Comput Tomogr. 2025 Jul-Aug;19(4):474-82).
A second generation of PCCT scanners based on silicon detectors (Si-PCCT) has recently been developed to overcome these limitations (Phys Med Biol.2021 Jan 29;66(3):03tr1). The physical properties of silicon detectors, combined with an edge-on detector geometry and depth-segmented pixels, provide superior count-rate capability, improved energy separation, and high spatial resolution. Preliminary phantom studies and early prototype investigations suggest that Si-PCCT may enable high-quality coronary imaging at substantially reduced radiation and contrast doses while offering reliable spectral information for advanced plaque analysis (Radiology. 2024 Jun;311(3):e231598). However, systematic clinical evidence in humans is currently sparse, particularly in the setting of cardiovascular imaging that requires fast acquisition and high temporal resolution.
The present clinical investigation addresses this critical knowledge gap. Its primary purpose is to evaluate the diagnostic performance, dose efficiency, and clinical feasibility of Si-PCCT for CCTA in direct comparison with established EID-CT and, where available, invasive coronary angiography. By prospectively evaluating low-dose acquisition protocols, comparing quantitative plaque burden and composition, and exploring the impact on diagnostic accuracy and functional assessment, this study aims to establish whether Si-PCCT can deliver clinically meaningful improvements beyond the current state of the art. The results are expected to provide essential evidence to guide safe clinical implementation of Si-PCCT and to inform future applications in cardiovascular risk stratification, prevention, and patient management.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Photon-counting computed tomography device with silicon-based detectors
| Arm | Type | Receives |
|---|---|---|
| Patients underdoing clinically indicated coronary CT angiography | Other | Device: Photon-counting computed tomographyAll participants will undergo both clinically indicated coronary CT on a conventional CT scanner plus additional coronary CT on the photon-counting CT scanner |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Referred for clinically indicated cardiac CT
- Age ≥18 years
- Informed Consent signed by the subject
Key exclusion criteria (4 listed)
- Known allergy to iodinated contrast
- Pregnancy
- Impaired renal function (eGFR<30ml/min/1.73m2)
- Any other common contraindication for routine cardiac CT or any other reason leading to the inability to successfully and completely perform routine cardiac CT with and without contrast-enhancement
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 |
|---|---|---|
| Photon-counting computed tomographyDevice is a novel second generation photon-counting CT device with silicon-based detectors | Device | Patients underdoing clinically indicated coronary CT angiography |
Primary outcome
Image quality of standard and low-dose Si-PCCT CCTA acquisition protocols versus the standard-of-care EID-CT CCTA protocol.
Time frame: Same day as enrollment
Proportion of patients with ≥95% interpretable coronary segments achieved with standard and low-dose Si-PCCT protocols vs. the reference protocols.
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 9 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Photon-counting computed tomography in people with Coronary Artery Disease, run by Ronny R Buechel, MD.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Ronny R Buechel, MD (+41442551059, ronny.buechel@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality of standard and low-dose Si-PCCT CCTA acquisition protocols versus the standard-of-care EID-CT CCTA protocol. (time frame: Same day as enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026.