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Clinical Trials/NCT06544681
NCT06544681
Not yet recruiting
Not Applicable

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

Xiang Ma0 sites2,000 target enrollmentAugust 20, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Disease
Sponsor
Xiang Ma
Enrollment
2000
Primary Endpoint
MACE
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 20, 2024
End Date
December 31, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Xiang Ma
Responsible Party
Sponsor Investigator
Principal Investigator

Xiang Ma

professor

First Affiliated Hospital of Xinjiang Medical University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

MACE

Time Frame: 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.

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