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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

Ronny R Buechel, MD contact

+41442551059

ronny.buechel@usz.ch

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.

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 groups in NCT07411196
Study groupRoleWhat they receive
Patients underdoing clinically indicated coronary CT angiographyOtherAll 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.

  1. 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.

  1. First posted13 Feb 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion30 Apr 2029 (estimated)
  4. Study completion30 Apr 2029 (estimated)

Resources

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)
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

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.

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