NCT07293858 Optical Coherence Tomography: Prognostic Value and Artificial Intelligence
| NCT ID | NCT07293858 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Radboud University Medical Center |
| Condition | Coronary Arterial Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2021-11-26 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2021-11-26 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07293858 clinical trial?
This trial is open to participants of all sexes, studying Coronary Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07293858 currently recruiting?
Yes, NCT07293858 is actively recruiting participants. Contact the research team at joske.vanderzande@radboudumc.nl for enrollment information.
Where is the NCT07293858 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands.
Who is sponsoring the NCT07293858 clinical trial?
NCT07293858 is sponsored by Radboud University Medical Center. The trial plans to enroll 1,000 participants.