Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07036770

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis CT Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia OCT Angiography Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, 3000, Belgium

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

Participants eligible for this study must not meet any of the following criteria:

  • Patients presenting with STEMI.
  • Haemodynamically unstable patients.
  • Unstable ventricular arrhythmias.
  • Killip class III-IV heart failure.
  • 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.
  • Severe coronary vessel tortuosity.
  • Subject has known hypersensitivity to radiocontrast dye or that cannot be adequately pre-medicated.
  • Female who is pregnant or breast-feeding.

Treatment and study plan

Coronary CT scan using photon-counting CT

Diagnostic Test

A dedicated cardiac UHR PCCT will be conducted within a maximum of 24 hours in ACS subjects and 72 hours in CCS subjects prior to the invasive CAG. Additionally, patients are also eligible for inclusion in case no PCCT is conducted prior to CAG, as long as no PCI is performed during the initial CAG. In these cases, the PCCT must be conducted within 24 hours for ACS patients and within 72 hours for CCS patients.

Primary outcomes

  1. Diagnostic accuracy of coronary PCCT angiography.

    Time frame: From PCCT until OCT run, completed within 72 hours.

    Assessment of co-primary endpoints luminal area (mm²), stenosis grade (%) and plaque content (mm²) of coronary PCCT as compared to OCT imaging.

Secondary outcomes

  1. High-risk plaque features.

    Time frame: From PCCT until OCT run, completed within 72 hours.

    Correlation of high-risk features on coronary PCCT with OCT findings, including presence of TCFA, lipid-rich plaque, macrophages, spotty calcification, microvessels, cholesterol crystal and/or layered plaque.

  2. Plaque volume.

    Time frame: From PCCT until IVUS run, completed within 72 hours.

    Comparison between plaque volume on coronary PCCT and IVUS (mm³).

  3. Coronary reconstruction algorithm.

    Time frame: From PCCT until OCT run, completed within 72 hours.

    Analysis of coronary artery reconstruction algorithm with PCCT as compared to invasive coronary angiogram (minimal lumen area; mm²).

Study contacts

Contact information is provided by the study sponsor or research team.

Pascal Frederiks, MD

CONTACT

[email protected]

+3216344235

Tim Busselot

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: C-EAGLE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.