Early Warning of Structural Complications in Perimembranous VSD
Early Warning of Structural Complications Related to Perimembranous Ventricular Septal Defect Using Unstructured Echocardiographic Text Mining and Machine Learning
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.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200092
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Training cohort
Participants from the multicenter retrospective dataset used for model development.
Unstructured echocardiographic text and clinical data from this cohort will be used for feature extraction, model training, and internal optimization to establish an early warning model for structural complications related to perimembranous ventricular septal defect.
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Validaction cohort
An independent subset of participants from the multicenter retrospective dataset used for model validation.
Data from this cohort will be used to evaluate the discrimination, calibration, and generalizability of the developed early warning model for structural complications related to perimembranous ventricular septal defect.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Occurrence of Perimembranous Ventricular Septal Defect Related Structural Complications
Prazo: From initial diagnosis through 3 years after diagnosis
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Occurrence of at least one structural complication related to perimembranous ventricular septal defect, as identified by echocardiography, including: (1) aortic valve prolapse and/or aortic regurgitation, defined as valvular leaflet displacement into the defect and/or regurgitation detected by color Doppler; (2) subaortic fibrous ridge, defined as abnormal fibrous strand or ridge-like echogenicity in the left ventricular outflow tract; (3) left ventricle-to-right atrium shunt; or (4) right ventricular outflow tract obstruction, defined as abnormal muscular bundle hypertrophy with increased Doppler flow velocity and a peak pressure gradient greater than 20 mmHg.
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From initial diagnosis through 3 years after diagnosis
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Area Under the Precision-Recall Curve (AUCPR) for Complication Prediction
Prazo: From initial diagnosis through 3 years after diagnosis
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The area under the precision-recall curve (AUCPR) of the model for predicting PMVSD-related complication endpoint.
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From initial diagnosis through 3 years after diagnosis
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Sensitivity of the Model at a Pre-Specified Risk Threshold
Prazo: From initial diagnosis through 3 years after diagnosis
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Sensitivity for predicting PMVSD-related complication endpoint at a pre-specified probability (risk) threshold.
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From initial diagnosis through 3 years after diagnosis
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Positive Predictive Value (PPV) of the Model at a Pre-Specified Risk Threshold
Prazo: From initial diagnosis through 3 years after diagnosis
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Positive predictive value (PPV) for predicting PMVSD-related complication endpoint at the same pre-specified probability (risk) threshold.
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From initial diagnosis through 3 years after diagnosis
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Negative Predictive Value (NPV) of the Model at a Pre-Specified Risk Threshold
Prazo: From initial diagnosis through 3 years after diagnosis
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Negative predictive value (NPV) for predicting PMVSD-related complication endpoint at the same pre-specified probability (risk) threshold.
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From initial diagnosis through 3 years after diagnosis
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Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- XHEC-C-2026-099
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