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

NCT ID: NCT06544681

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-20

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Coronary Disease Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Coronary Stent Malapposition

Measurement results of deep learning-based OCT system: Coronary Stent Malapposition

Coronary stenting with planned drug eluting stent (DES).

Intervention Type PROCEDURE

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

Coronary stenting with planned drug eluting stent (DES).

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shihezi University

OTHER

Sponsor Role collaborator

Xiang Ma

OTHER

Sponsor Role lead

Responsible Party

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Xiang Ma

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Pengfei Liu, M.D

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Xinjiang Medical University

Xinliang Peng, M.D

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Xinjiang Medical University

Abudusalamu Tuerdimaimaiti, M.D

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Xinjiang Medical University

Central Contacts

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Xiang Ma, Ph.D

Role: CONTACT

+86 13669939349

Pengfei Liu, M.D

Role: CONTACT

+86 18653773715

Other Identifiers

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2022B03022-3

Identifier Type: -

Identifier Source: org_study_id

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