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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy and limitations of photon-counting computed tomography (PCCT) for assessing coronary plaque in patients with acute or chronic coronary syndrome. The study aims to determine if cardiac ultra-high resolution PCCT, which offers better spatial resolution and soft tissue contrast than conventional CT, can be a reliable, non-invasive alternative to invasive imaging methods like optical coherence tomography (OCT) and intravascular ultrasound (IVUS). This observational study will enroll 100 patients, including subgroups with suspected in-stent restenosis and those one year after percutaneous coronary intervention for chronic total occlusion. Participants will undergo a dedicated cardiac ultra-high resolution PCCT scan within 24 hours for acute coronary syndrome patients or within 72 hours for chronic coronary syndrome patients, scheduled before invasive coronary angiography. Alongside PCCT, invasive OCT will be performed during angiography, and a subgroup of 10 patients will also have IVUS imaging to allow direct comparison of these methods. The study evaluates PCCT's ability to characterize plaque features, measure plaque volume, and support coronary reconstruction. During the study, participants will have PCCT imaging shortly before invasive angiography, followed by OCT and, for some, IVUS. Researchers will assess the diagnostic accuracy of PCCT compared to OCT within 72 hours, focusing on high-risk plaque features and plaque volume. The study involves careful monitoring of imaging results and clinical data to understand how PCCT findings correlate with established invasive imaging techniques. The total participation duration depends on the timing of these procedures but includes assessments completed within a few days of each other.
CONDITIONS
Brief 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...
- Provide voluntary written informed consent before screening.
- Be at least 18 years old at the time of consent.
- Have suspected acute coronary syndrome (unstable angina or NSTEMI) or chronic coronary syndrome (stable angina or silent ischemia).
You will not qualify if you...
- Have ST-elevation myocardial infarction (STEMI).
- Be hemodynamically unstable.
- Have unstable ventricular arrhythmias.
- Be classified as Killip class III-IV heart failure.
- Have creatinine clearance below 30 ml/min/1.73 m2 and not be on dialysis.
- Have severe coronary vessel tortuosity.
- Have known hypersensitivity to radiocontrast dye that cannot be pre-medicated.
- Be pregnant or breastfeeding.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 24 to 72 hours before invasive coronary angiography
Participants undergo a coronary CT scan using photon-counting CT to evaluate coronary lesions prior to invasive coronary angiography.
1 visit (in-person)
Duration - Up to 72 hours after imaging
Participants are observed after diagnostic imaging to assess coronary conditions without active intervention.
1 to 2 visits depending on diagnostic procedures
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
P
Pascal Frederiks, MD
T
Tim Busselot
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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