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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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06544681
Enrollment
2000
Registered
2024-08-09
Start date
2024-08-20
Completion date
2026-12-31
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Coronary Disease

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.

Interventions

PROCEDURECoronary 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.

Sponsors

Shihezi University
CollaboratorOTHER
Xiang Ma
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
MACEPost-procedure within 1 yearPatients 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.

Contacts

Primary ContactXiang Ma, Ph.D
maxiangxj@yeah.net+86 13669939349
Backup ContactPengfei Liu, M.D
liupf918@126.com+86 18653773715

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026