Optical Coherence Tomography: Prognostic Value and Artificial Intelligence (ORANGE)

Radboud University Medical Center

Status: Enrolling

Conditions: Coronary Arterial Disease

Study type: Observational

Funder types: Other

Identifiers

NCT07293858

2021-13271

Details and patient eligibility

About

This study aims to evaluate the prognostic value of optical coherence tomography (OCT) imaging of the coronary arteries. OCT provides high-resolution images of the vessel wall and stented segments during routine cardiac catheterization. All patients who undergo OCT as part of their clinical care are invited to participate in this prospective registry.

The study will examine whether specific OCT-derived characteristics-such as plaque morphology, vulnerable features, or indicators of stent optimization-are associated with long-term clinical outcomes. Follow-up information on symptoms, medication use, hospitalizations, cardiac procedures, and major cardiac events will be collected through medical records, questionnaires, and national registry data over a period of up to 10 years.

In addition, pseudonymized OCT pullbacks will be used to support the development of an artificial intelligence (AI) algorithm for automated annotation of OCT images. This algorithm may help improve the clinical interpretation of OCT by identifying relevant imaging features in a consistent and efficient manner.

Participation is voluntary and includes permission to use clinical data, OCT images, and follow-up information for research purposes. Data are coded to protect participant privacy and stored securely according to applicable regulations. The results of this study may contribute to better understanding of coronary plaque characteristics and may support improved decision-making in interventional cardiology.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All consecutive patients undergoing intracoronary OCT imaging at the Radboud University Medical Center, and any additional centers that may join the study in the future.
• OCT performed at the discretion of the treating physician, according to contemporary clinical guidelines.
• Written informed consent obtained after the procedure.

Exclusion criteria

• Patients who decline or are unable to provide informed consent. (Only patients who provide consent can be included.
• Patients for whom follow-up or data collection is not feasible (e.g., no valid contact details).