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NCT07662343

Early Warning of Structural Complications in Perimembranous VSD

Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

0 Years - 14 Years

Study Type

OBSERVATIONAL

Enrollment

11683

Start Date

2004-01-01

Completion Date

2027-07-01

Last Updated

2026-06-23

Healthy Volunteers

No

Locations (1)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China