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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UZ Leuven
  Leuven, Belgium Recruiting

Study contacts

• Principal investigator: Tom Adriaenssens, MD PhD — UZ Leuven
• Study coordinator: Pascal Frederiks, MD
• Email: pascal.frederiks@uzleuven.be
• Phone: +3216344235

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.