Evaluation and Treatment Strategy Development of Coronary Heart Disease Guided by OCT Based on Multimodal Deep Learning

Not yet recruiting

• Conditions: Coronary Disease; Coronary Artery Disease
• Interventions: Procedure: Coronary stenting with planned drug eluting stent (DES).

• Registration Number: NCT06544681
• Lead Sponsor: Xiang Ma

Brief Summary

This is a retrospective, multicenter, observational study aimed at assessing stent apposition for coronary stent implantation by an optical coherence tomography system constructed by deep learning algorithms and evaluating the prognosis of patients after stent implantation in conjunction with multimodal diagnostic and therapeutic information.

Detailed Description

In this study, we planned to retrospectively collect 2,000 subjects who underwent optical coherence tomography-guided percutaneous coronary stent implantation with an optical coherence tomography system constructed by a deep learning algorithm from 3 centers to assess stent apposition for coronary stent implantation, and to classify subjects into a group with poor stent apposition (axial distance \>400 μm or length \>1 mm) and a group with good stent apposition. All subjects were followed up within 12 months after the procedure.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-05
• Study First Submitted QC: 2024-08-05
• Last Update Submitted: 2024-08-05
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Study Start: 2024-08-20
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Age ≥20 years old;
• Angiography was performed, and OCT imaging of criminal blood vessels was performed before intervention;
• Type of coronary heart disease: Unstable angina pectoris (UA), ST elevation myocardial infarction (STEMI) And non-ST elevation myocardial infarction (NSTEMI);

Exclusion Criteria

• Lack of medical records;
• Failure to complete follow-up;
• Previous coronary artery bypass grafting;
• Severe liver or kidney insufficiency;
• Infectious diseases, malignancies and bleeding diseases;
• OCT image quality was caused by large thrombus volume or residual blood in lumen and percutaneous coronary angiography Poor and further excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary Stent Malapposition	Coronary stenting with planned drug eluting stent (DES).	Measurement results of deep learning-based OCT system: Coronary Stent Malapposition
Coronary Stent Well Apposed	Coronary stenting with planned drug eluting stent (DES).	Measurement results of a deep learning-based OCT system: Coronary Stent Well Apposed

Primary Outcome Measures

Name	Time	Method
MACE	Post-procedure within 1 year	Patients were followed up within 1 year after OCT and PCI. The follow-up included major adverse cardiac events: All causes were death, recurrent myocardial infarction, target vessel reconstruction, and stent thrombosis.