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临床试验/NCT07662343
NCT07662343进行中(未招募)不适用

Early Warning of Structural Complications Related to Perimembranous Ventricular Septal Defect Using Unstructured Echocardiographic Text Mining and Machine Learning

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 11,683 人开始时间: 2004年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
11,683
试验地点
1

研究概览

简要总结

The goal of this observational study is to develop and test a AI-based prediction model for children with perimembranous ventricular septal defect, also called PMVSD. PMVSD is a type of hole between the lower chambers of the heart. Some children with PMVSD may later develop heart structure problems, such as aortic valve prolapse or leakage, subaortic fibrous ridge, left ventricle-to-right atrium shunt, or right ventricular outflow tract obstruction.

This study will use past medical records and echocardiography reports from children who received care at six hospitals in China between 2004 and 2022. The main questions it aims to answer are:

Can information written in echocardiography reports help predict which children with PMVSD are more likely to develop heart structure problems? Can natural language processing and machine learning improve early risk prediction when used together with routine clinical information? Researchers will review existing, de-identified medical data. They will use natural language processing to turn written descriptions in echocardiography reports into data that a computer model can analyze. These descriptions may include details about the edge of the heart defect, the direction of blood flow, and the relationship between the defect and nearby heart valves.

Participants will not receive any study treatment or extra tests. The study will only use information already collected during routine medical care. The prediction models will be trained and tested using data from different hospitals to see how well they work across medical centers.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
0 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 14 years or younger at the time of presentation/diagnosis;
  • Confirmed diagnosis of perimembranous ventricular septal defect (PMVSD), or PMVSD accompanied by minor cardiac anomalies that do not alter the hemodynamic status of the VSD, including small patent foramen ovale, atrial septal defect, patent ductus arteriosus, or persistent left superior vena cava;
  • Availability of at least two consecutive follow-up records, with consistency between the electronic echocardiography reports and the Hospital Information System data.

排除标准

  • Age older than 14 years at diagnosis;
  • Presence of complex congenital heart disease;
  • Patients lost to follow-up due to inability to establish contact, resulting in an indeterminate clinical outcome.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kun Sun

Professor of Department of Pediatric Cardiology

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

研究点 (1)

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