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

NCT07036770 | Recruiting

• 1 other identifier: S70500
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Coronary Artery Disease; OCT Angiography; CT

Keywords

PCCT

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of coronary PCCT angiography.

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

  From PCCT until OCT run, completed within 72 hours.

Secondary Outcomes (3)

• High-risk plaque features.

  From PCCT until OCT run, completed within 72 hours.

• Plaque volume.

  From PCCT until IVUS run, completed within 72 hours.

• Coronary reconstruction algorithm.

  From PCCT until OCT run, completed within 72 hours.

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study aims to enrol 100 patients with acute or chronic coronary syndrome, including 40 participants with suspected in-stent restenosis and 10 participants one year after a CTO PCI.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Tom Adriaenssens, MD PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal Frederiks, MD

CONTACT

+3216344235; pascal.frederiks@uzleuven.be

Tim Busselot

CONTACT

tim.busselot@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 25, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 25, 2025

Record last verified: 2025-05

Locations

BE (1)