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

NCT06544681 | Not Yet Recruiting

• 1 other identifier: 2022B03022-3
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Disease; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Coronary Stent Malapposition

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

Procedure: Coronary stenting with planned drug eluting stent (DES).

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).

Interventions

Coronary stenting with planned drug eluting stent (DES). 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 Malapposition; Coronary Stent Well Apposed

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiang Ma: lead
• Shihezi University: collaborator

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang Ma, Ph.D

CONTACT

+86 13669939349; maxiangxj@yeah.net

Pengfei Liu, M.D

CONTACT

+86 18653773715; liupf918@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: August 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08