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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Coronary Disease
• Intervention / Treatment: Procedure: Coronary stenting with planned drug eluting stent (DES).

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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Xiang Ma, Ph.D; Phone Number: +86 13669939349; Email: maxiangxj@yeah.net
• Study Contact Backup: Name: Pengfei Liu, M.D; Phone Number: +86 18653773715; Email: liupf918@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Retrospective data were collected from the First Affiliated Hospital of Xinjiang Medical University and Jining, Shandong Province from 2015 to 2022 Coronary artery disease patients undergoing coronary angiography and OCT examination in the First People's Hospital of China and Xigu District People's Hospital of Gansu Province.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Coronary Stent Malapposition; Measurement results of deep learning-based OCT system: Coronary Stent Malapposition	Procedure: Coronary stenting with planned drug eluting stent (DES).; Stenting will be performed with OCT guidance according to the algorithm described in the protocol. A deep learning-based OCT system was used to measure the adherence of coronary stents.
Coronary Stent Well Apposed; Measurement results of a deep learning-based OCT system: Coronary Stent Well Apposed	Procedure: Coronary stenting with planned drug eluting stent (DES).; Stenting will be performed with OCT guidance according to the algorithm described in the protocol. A deep learning-based OCT system was used to measure the adherence of coronary stents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	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.	Post-procedure within 1 year

Collaborators and Investigators

• Sponsor: Xiang Ma
• Collaborators: Shihezi University
• Investigators: Principal Investigator: Pengfei Liu, M.D, First Affiliated Hospital of Xinjiang Medical University; Principal Investigator: Xinliang Peng, M.D, First Affiliated Hospital of Xinjiang Medical University; Principal Investigator: Abudusalamu Tuerdimaimaiti, M.D, First Affiliated Hospital of Xinjiang Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): August 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2022B03022-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes