About this trial
This study evaluates the diagnostic accuracy and limitations of photon-counting computed tomography (PCCT) in characterizing coronary plaque, with comparisons to optical coherence tomography (OCT) and intravascular ultrasound (IVUS). The objective is to assess whether cardiac ultra-high resolution (UHR) PCCT -with its improved spatial resolution and superior soft tissue contrast relative to conventional CT- can serve as a reliable, non-invasive alternative for coronary plaque assessment and support clinical decision-making. A total of 100 patients with either acute or chronic coronary syndrome will be enrolled, including 40 individuals with suspected in-stent restenosis and 10 patients one year post-percutaneous coronary intervention (PCI) for chronic total occlusion (CTO). All participants will undergo invasive coronary angiography based on current European Society of Cardiology guidelines. Cardiac PCCT imaging will be conducted shortly before the angiographic procedure, accompanied by invasive OCT evaluation. Additionally, a subgroup of 10 patients will undergo both OCT and IVUS, allowing for direct comparison across imaging modalities. OCT, regarded as the gold standard for plaque characterization, offers near-histological resolution for identifying plaque features, while IVUS is particularly effective in evaluating plaque burden and volume.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
At least 18 years of age at the time of signing the Informed Consent Form (ICF).
Patients presenting with suspected acute coronary syndrome (UA or NSTEMI) or chronic coronary syndrome (stable angina or silent ischemia).
Disqualifiers
Patients presenting with STEMI.
Haemodynamically unstable patients.
Unstable ventricular arrhythmias.
Killip class III-IV heart failure.
Trial population
The study aims to enrol 100 patients with acute or chronic coronary syndrome, including 40 participants with suspected in-stent restenosis and 10 participants one year after a CTO PCI.
Trial design
Cohort
Prospective
Treatments tested in this trial
Coronary CT scan using photon-counting CT
Diagnostic testA dedicated cardiac UHR PCCT will be conducted within a maximum of 24 hours in ACS subjects and 72 hours in CCS subjects prior to the invasive CAG. Additionally, patients are also eligible for inclusion in case no PCCT is conducted prior to CAG, as long as no PCI is performed during the initial CAG. In these cases, the PCCT must be conducted within 24 hours for ACS patients and within 72 hours for CCS patients.
Treatment groups
Trial outcomes
Primary outcomes
Diagnostic accuracy of coronary PCCT angiography.
Assessment of co-primary endpoints luminal area (mm²), stenosis grade (%) and plaque content (mm²) of coronary PCCT as compared to OCT imaging.
Secondary outcomes
High-risk plaque features.
Correlation of high-risk features on coronary PCCT with OCT findings, including presence of TCFA, lipid-rich plaque, macrophages, spotty calcification, microvessels, cholesterol crystal and/or layered plaque.
Plaque volume.
Comparison between plaque volume on coronary PCCT and IVUS (mm³).
Coronary reconstruction algorithm.
Analysis of coronary artery reconstruction algorithm with PCCT as compared to invasive coronary angiogram (minimal lumen area; mm²).
Sponsors and contacts
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