Optical Coherence Tomography: Prognostic Value and Artificial Intelligence

NCT07293858 | Recruiting

• 1 other identifier: 2021-13271
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Arterial Disease

Keywords

Optical Coherence Tomography; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• Relationship between OCT-derived plaque and stent characteristics and long-term clinical outcomes

  Assessment of whether specific OCT-derived characteristics-such as plaque morphology, vulnerable features, stent deployment quality, and other intraluminal or vessel wall findings-are associated with long-term clinical outcomes. Outcomes include cardiac symptoms, cardiac events, coronary interventions, hospitalization, and death, based on medical records, questionnaire data, and national registries.

  10 years

Secondary Outcomes (1)

• Performance of an automated OCT annotation algorithm

  Baseline (OCT acquisition) to algorithm development period (≤5 years)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of all patients who have undergone intracoronary OCT imaging of the coronary arteries as part of their routine cardiac catheterization. This is an all-comer population with no restrictions regarding indication, diagnosis, age, or comorbidities. The decision to perform OCT is made independently by the treating cardiologist. After the procedure, patients are invited to participate in this prospective registry and are included only after providing written informed consent.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

RECRUITING

Central Study Contacts

Joske L. van der Zande

CONTACT

0622997212; joske.vanderzande@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: November 26, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

NL (1)