NCT07036770Recruiting
Coronary Evaluation And Guided Lesion Exploration Using Photon-counting CT and Intracoronary Imaging Techniques
Source: ClinicalTrials.gov · Last updated 25 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 26 May 2025
- Start date
- 16 Jun 2025
- Primary completion date
- 31 May 2027
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Diseases
- Coronary artery disease
- NCT number
- NCT07036770
What you commit to
- Study type: Observational
- Planned participants: 100
- From 16 Jun 2025 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Unstable ventricular arrhythmias.
- Killip class III-IV heart failure.
- Subject has known hypersensitivity to radiocontrast dye or that cannot be adequately pre-medicated.
Lab values
- 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.
Other
- Participants eligible for this study must not meet any of the following criteria:
- Patients presenting with STEMI.
- Haemodynamically unstable patients.
- Severe coronary vessel tortuosity.
- Female who is pregnant or breast-feeding.
Who the study is looking for
- Participants eligible for inclusion in this study must meet all of the following criteria:
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- At least 18 years of age at the time of signing the Informed Consent Form (ICF).
- Patients presenting with suspected acute coronary syndrome (UA or NSTEMI) or chronic coronary syndrome (stable angina or silent ischemia).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.