NCT07411196

Brief 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 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
30mo left

Started Aug 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2029

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

February 3, 2026

Last Update Submit

February 10, 2026

Conditions

Keywords

coronary artery diseasephoton-counting computed tomographycoronary computed tomography angiography

Outcome Measures

Primary Outcomes (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.

    Same day as enrollment

Study Arms (1)

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

Device: Photon-counting computed tomography

Interventions

Device is a novel second generation photon-counting CT device with silicon-based detectors

Patients underdoing clinically indicated coronary CT angiography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Referred for clinically indicated cardiac CT
  • Age ≥18 years
  • Informed Consent signed by the subject

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Ronny R Buechel, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Photon-counting computed tomography device with silicon-based detectors
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy Director of the Department of Nuclear Medicine

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 13, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

January 31, 2029

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share