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临床试验/NCT06611995
NCT06611995尚未招募不适用

Prediction of Stroke Risk in Patients with Atrial Fibrillation Based on Chest CT Images

First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2024年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,500
试验地点
1
主要终点
Performance of a Deep Learning Framework for Predicting Ischemic Stroke Risk in AF Patients.

研究概览

简要总结

This study aims to create and assess a deep learning framework for extracting left atrial appendage features in atrial fibrillation patients and combining them with clinical data to predict ischemic stroke risk. Clinical data and chest CT images from patients diagnosed with non-valvular atrial fibrillation will be collected. Patients will be categorized into stroke and non-stroke groups to build a data repository. The dataset will be divided into training and validation sets, with missing data handled and pulmonary vein CTV and virtual non-contrast images annotated. A deep learning model will be used for image segmentation and feature extraction to develop a prediction system.

详细描述

This study aims to develop and evaluate a deep learning framework that can automatically extract imaging features of the left atrial appendage in patients with atrial fibrillation and combine them with clinical features to predict the risk of ischemic stroke in these patients. The study intends to retrospectively collect clinical data (including patients' general information, medical history, laboratory tests, etc.) and chest CT images, as well as pulmonary vein CTV images (if available), from patients diagnosed with non-valvular atrial fibrillation between January 2018 and June 2024. The patients will be divided into stroke and non-stroke groups based on whether they have experienced an ischemic stroke, and a data analysis repository will be established. The dataset will be split into training and validation sets. Missing data will be handled, and data labeling will be performed on the pulmonary vein CTV sequence images and virtual non-contrast (VNC) sequence images. The left atrial morphology will be delineated, and a deep learning-based image segmentation network model will be developed to extract and select radiomic features for the prediction system.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosed with atrial fibrillation by ECG, 24-hour Holter monitor, or recordable ECG monitor; atrial fibrillation confirmed by an implanted pacemaker or defibrillator, lasting at least 30 seconds Available chest CT images and complete clinical data.

排除标准

  • Incomplete clinical data or diagnosis of valvular atrial fibrillation (e.g., rheumatic heart valve disease, post-valve replacement) Poor-quality CT images that prevent complete assessment of left atrial appendage morphology Patients who have undergone left atrial appendage closure Patients who have had radiofrequency ablation or cardioversion with no evidence of recurrence post-procedure

结局指标

主要结局

Performance of a Deep Learning Framework for Predicting Ischemic Stroke Risk in AF Patients.

时间窗: Through study completion, an average of 2 year.

This study aims to develop and evaluate a deep learning framework that automatically extracts Left Atrial Appendage (LAA) imaging features from 3D_slicer software and combines them with clinical characteristics to predict ischemic stroke risk in patients with atrial fibrillation (AF). The performance of the developed system will be evaluated using receiver operating characteristic (ROC) curves, area under the curve (AUC), accuracy, sensitivity, and specificity.

次要结局

未报告次要终点

研究者

发起方
First Affiliated Hospital of Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hu Xiaosheng

Chief Physician

First Affiliated Hospital of Zhejiang University

研究点 (1)

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