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

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Jun 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of heart scan called photon-counting computed tomography (PCCT) to see how well it can detect and describe blockages or plaques in the heart’s arteries. These plaques can cause heart problems like chest pain or heart attacks. Researchers want to find out if this new scan, which provides very detailed images without needing to insert tubes into the arteries, can be as accurate as the current methods that do require invasive procedures, like optical coherence tomography (OCT) and intravascular ultrasound (IVUS). The goal is to see if PCCT could become a safer, easier way to help doctors decide the best treatment for patients with heart artery disease.

People who might join this study are adults 18 years or older who have symptoms of heart artery problems, such as chest pain or other signs of heart trouble, but who are not experiencing the most severe heart attacks. Participants will have the new PCCT scan shortly before undergoing a standard invasive heart artery test, where a thin tube is inserted to get detailed images from inside the arteries. Some will also have additional imaging tests for comparison. This study will include about 100 patients, including some who have had previous heart procedures like stents placed in their arteries. It’s important that participants are stable enough for these tests and don’t have certain conditions like severe kidney problems or allergies to the dye used in scans. Overall, if you join, you can expect thorough heart imaging with both new and standard methods to help doctors learn more about how well this new scanning technology works.

Gender

ALL

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.