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临床试验/NCT06341361
NCT06341361尚未招募不适用

Optical Coherence Tomography-based Machine Learning for Predicting Fractional Flow Reserve After Coronary Artery Stenting

Yonsei University0 个研究点目标入组 82 人开始时间: 2024年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
82
主要终点
Correlation of OCT-based machine learning FFR compared to wire-based FFR

研究概览

简要总结

This study aims to compare the diagnostic accuracy of the fractional flow reserve (FFR) model derived by machine learning based on optical coherence tomography (OCT) exam after coronary artery stent implantation with the wire-based FFR.

详细描述

FFR and OCT exam are used for different purposes during percutaneous coronary intervention (PCI). The FFR is a decision-making tool to determine if additional procedures are necessary, while the OCT exam is used to optimize the stent procedure. The use of both tests provides additional information to help perform a excellent procedure, but it is more expensive and time-consuming.

Therefore, an OCT-derived machine learning FFR test may be helpful. Previous studies have demonstrated that OCT-based machine learning FFR before the procedure has shown good diagnostic performance in predicting FFR, irrespective of the coronary territory.

Despite the rapid development of technologies and tools for PCI, a significant number of patients experienced adverse events, such as recurrence of angina and silent ischemia despite angiographically successful PCI. Suboptimal PCI is a well-known independent prognostic factor for major cardiovascular accidents. Therefore, measuring post-PCI FFR immediately after stent implantation is crucial to optimize the procedure outcome and improve the patient's prognosis. Although the importance of measuring post-PCI FFR is gradually emerging, there is currently no model for OCT-based machine learning FFR that predicts FFR after stent insertion. In patients who underwent percutaneous coronary intervention using stents for ischemic heart disease, we will compare the diagnostic accuracy of the fractional flow reserve (FFR) model derived by machine learning based on optical coherence tomography (OCT) exam after coronary artery stent implantation with the wire-based FFR.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who underwent stent implantation for ischemic heart disease
  • Patients who underwent both OCT examination and FFR using a pressure wire after PCI

排除标准

  • Poor OCT imaging quality
  • Patients with severe left ventricular dysfunction (<30%)
  • Patients with severe valvular heart disease
  • Patients with a life expectancy of less than 1 year

结局指标

主要结局

Correlation of OCT-based machine learning FFR compared to wire-based FFR

时间窗: 4 weeks

Determining the diagnostic accuracy of CT-FFR values obtained by the new method compared with invasive coronary angiography with fractional flow reserve

次要结局

  • Diagnostic performance of OCT-based machine learning FFR compared to wire-based FFR(4 weeks)
  • Diagnostic performance of OCT-based machine learning FFR according to the coronary artery (LAD, LCx or RCA) compared to wire-based FFR(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jung-Sun Kim

Professor

Yonsei University

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