Coronary Evaluation And Guided Lesion Exploration Using Photon-counting CT and Intracoronary Imaging Techniques
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coronary CT scan using photon-counting CT.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, OCT Angiography, CT. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test Coronary CT scan using photon-counting CT
A 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.
Primary outcome measures
- Diagnostic accuracy of coronary PCCT angiography. [Time frame: From PCCT until OCT run, completed within 72 hours.]
Secondary outcome measures (3)
- High-risk plaque features. [Time frame: From PCCT until OCT run, completed within 72 hours.]
- Plaque volume. [Time frame: From PCCT until IVUS run, completed within 72 hours.]
- Coronary reconstruction algorithm. [Time frame: From PCCT until OCT run, completed within 72 hours.]
Eligibility criteria
Inclusion criteria
Participants eligible for inclusion in this study must meet all of the following criteria:
- 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).
Exclusion criteria
Participants eligible for this study must not meet any of the following criteria:
- Patients presenting with STEMI.
- Haemodynamically unstable patients.
- Unstable ventricular arrhythmias.
- Killip class III-IV heart failure.
- Creatinine clearance <30 ml/min/1.73 m2 (as calculated by CKD-EPI formula 2009 for estimated GFR) and not on dialysis. Note: patients dependent on long-term dialysis are eligible for enrolment irrespective of their creatinine clearance levels.
- Severe coronary vessel tortuosity.
- Subject has known hypersensitivity to radiocontrast dye or that cannot be adequately pre-medicated.
- Female who is pregnant or breast-feeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- UZ Leuven — Leuven
Identifiers
NCT: NCT07036770 · S70500