OCT-based Machine Learning FFR for Predicting Post-PCI FFR

Not yet recruiting

• Conditions: Fractional Flow Reserve, Myocardial; Tomography, Optical Coherence

• Registration Number: NCT06341361
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-03-26
• Last Update Submitted: 2024-03-26
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02
• Study Start: 2024-04-15
• Primary Completion: 2024-04-30
• Study Completion: 2025-10-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of OCT-based machine learning FFR compared to wire-based FFR	4 weeks	Determining the diagnostic accuracy of CT-FFR values obtained by the new method compared with invasive coronary angiography with fractional flow reserve

Secondary Outcome Measures

Name	Time	Method
Diagnostic performance of OCT-based machine learning FFR compared to wire-based FFR	4 weeks	Accuracy, sensitivity, specificity, positive predictive value, negative predictive value
Diagnostic performance of OCT-based machine learning FFR according to the coronary artery (LAD, LCx or RCA) compared to wire-based FFR	4 weeks	Accuracy, sensitivity, specificity, positive predictive value, negative predictive value