Actively Recruiting

Age: 18Years +
All Genders
NCT07036770

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

UZ Leuven

Leuven, Belgium, 3000

Actively Recruiting

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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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