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Early Warning of Structural Complications in Perimembranous VSD

22 giugno 2026 aggiornato da: Kun Sun, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Tipo di studio

Osservativo

Iscrizione (Stimato)

11683

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Cina
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, Cina, 200092
    - Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Bambino

Accetta volontari sani

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Pediatric patients with perimembranous ventricular septal defect evaluated at six tertiary referral centers between 2004 and 2022.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Numero di gruppi/coorti

Coorti e interventi

Gruppo / Coorte
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.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Occurrence of Perimembranous Ventricular Septal Defect Related Structural Complications Lasso di tempo: From initial diagnosis through 3 years after diagnosis	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.	From initial diagnosis through 3 years after diagnosis

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Area Under the Precision-Recall Curve (AUCPR) for Complication Prediction Lasso di tempo: From initial diagnosis through 3 years after diagnosis	The area under the precision-recall curve (AUCPR) of the model for predicting PMVSD-related complication endpoint.	From initial diagnosis through 3 years after diagnosis
Sensitivity of the Model at a Pre-Specified Risk Threshold Lasso di tempo: From initial diagnosis through 3 years after diagnosis	Sensitivity for predicting PMVSD-related complication endpoint at a pre-specified probability (risk) threshold.	From initial diagnosis through 3 years after diagnosis
Positive Predictive Value (PPV) of the Model at a Pre-Specified Risk Threshold Lasso di tempo: From initial diagnosis through 3 years after diagnosis	Positive predictive value (PPV) for predicting PMVSD-related complication endpoint at the same pre-specified probability (risk) threshold.	From initial diagnosis through 3 years after diagnosis
Negative Predictive Value (NPV) of the Model at a Pre-Specified Risk Threshold Lasso di tempo: From initial diagnosis through 3 years after diagnosis	Negative predictive value (NPV) for predicting PMVSD-related complication endpoint at the same pre-specified probability (risk) threshold.	From initial diagnosis through 3 years after diagnosis

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2004

Completamento primario (Effettivo)

1 gennaio 2022

Completamento dello studio (Stimato)

1 luglio 2027

Date di iscrizione allo studio

Primo inviato

1 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

22 giugno 2026

Primo Inserito (Effettivo)

23 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)