Actively Recruiting
Coronary Evaluation And Guided Lesion Exploration Using Photon-counting CT and Intracoronary Imaging Techniques
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-06-25
100
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Coronary Evaluation And Guided Lesion Exploration Using Photon-counting CT and Intracoronary Imaging Techniques
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent obtained before screening procedures
- At least 18 years old at the time of signing the consent form
- Patients with suspected acute coronary syndrome (unstable angina or NSTEMI) or chronic coronary syndrome (stable angina or silent ischemia)
You will not qualify if you...
- Patients with STEMI
- Hemodynamically unstable patients
- Unstable ventricular arrhythmias
- Killip class III-IV heart failure
- Creatinine clearance below 30 ml/min/1.73 m2 and not on dialysis (dialysis patients are eligible)
- Severe coronary vessel tortuosity
- Known hypersensitivity to radiocontrast dye not manageable with pre-medication
- Pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
P
Pascal Frederiks, MD
CONTACT
T
Tim Busselot
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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