Optical Coherence Tomography: Prognostic Value and Artificial Intelligence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-26

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Arterial Disease

Keywords

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Optical Coherence Tomography Artificial Intelligence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Radboudumc

Nijmegen, Gelderland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Joske L. van der Zande

Role: CONTACT

Phone: 0622997212

Email: [email protected]

Facility Contacts

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Niels van Royen, Prof. dr.

Role: primary

Other Identifiers

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2021-13271

Identifier Type: -

Identifier Source: org_study_id