Photon-counting CT with intracoronary imaging for detailed coronary plaque characterization

Coronary Evaluation And Guided Lesion Exploration Using Photon-counting CT and Intracoronary Imaging Techniques

This will test whether ultra–high-resolution photon-counting CT can reliably characterize coronary plaque compared with OCT and IVUS in adults with acute or chronic coronary syndrome, including patients with suspected in-stent restenosis or prior PCI for chronic total occlusion.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Universitaire Ziekenhuizen KU Leuven (Academic / other)
• Locations: 1 site (Leuven)
• Trial ID: NCT07036770 on ClinicalTrials.gov

What this trial studies

This observational study will enroll 100 adults presenting with either acute (UA/NSTEMI) or chronic coronary syndrome and perform cardiac photon-counting CT shortly before clinically indicated invasive coronary angiography. During angiography, intracoronary imaging such as optical coherence tomography (OCT) and intravascular ultrasound (IVUS) will be acquired as reference standards for plaque morphology. The primary goal is to determine the diagnostic accuracy and limitations of photon-counting CT for plaque characterization and to compare its findings to OCT/IVUS. The cohort includes targeted subgroups (40 with suspected in-stent restenosis and 10 one year post-PCI for CTO) to examine performance in common clinical scenarios.

Who should consider this trial

Good fit: Adults (≥18 years) with suspected acute coronary syndrome (UA or NSTEMI) or chronic coronary syndrome who are stable enough for scheduled PCCT and invasive coronary angiography are ideal candidates.

Not a fit: Patients with STEMI, hemodynamic instability, unstable ventricular arrhythmias, Killip class III–IV heart failure, or severe renal impairment (creatinine clearance <30 ml/min/1.73 m2 unless on dialysis) are unlikely to benefit or be eligible for this protocol.

Why it matters

Potential benefit: If successful, photon-counting CT could provide accurate, non-invasive plaque characterization that helps guide treatment decisions and may reduce reliance on invasive intracoronary imaging.

How similar studies have performed: Photon-counting CT is an emerging technology with promising early data on improved spatial resolution and soft-tissue contrast, but direct head-to-head comparisons with intracoronary OCT/IVUS for coronary plaque characterization remain limited.

Eligibility criteria

Inclusion criteria:

Participants eligible for inclusion in this study must meet all of the following criteria:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
2. At least 18 years of age at the time of signing the Informed Consent Form (ICF).
3. 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:

1. Patients presenting with STEMI.
2. Haemodynamically unstable patients.
3. Unstable ventricular arrhythmias.
4. Killip class III-IV heart failure.
5. 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.
6. Severe coronary vessel tortuosity.
7. Subject has known hypersensitivity to radiocontrast dye or that cannot be adequately pre-medicated.
8. Female who is pregnant or breast-feeding.

Where this trial is running

Leuven

• UZ Leuven — Leuven, Belgium (Recruiting)

Study contacts

• Principal investigator: Tom Adriaenssens, MD PhD — UZ Leuven
• Study coordinator: Pascal Frederiks, MD

Conditions Coronary Artery Disease; OCT Angiography; CT; PCCT