Optical Coherence Tomography: Prognostic Value and Artificial Intelligence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Relationship between OCT-derived plaque and stent characteristics and long-term clinical outcomes
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Relationship between OCT-derived plaque and stent characteristics and long-term clinical outcomes
时间窗: 10 years
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.
次要结局
- Performance of an automated OCT annotation algorithm(Baseline (OCT acquisition) to algorithm development period (≤5 years))