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Early Warning of Structural Complications in Perimembranous VSD

22 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Studietype

Observationeel

Inschrijving (Geschat)

11683

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Kind

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Occurrence of Perimembranous Ventricular Septal Defect Related Structural Complications Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Area Under the Precision-Recall Curve (AUCPR) for Complication Prediction Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 januari 2004

Primaire voltooiing (Werkelijk)

1 januari 2022

Studie voltooiing (Geschat)

1 juli 2027

Studieregistratiedata

Eerst ingediend

1 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 juni 2026

Eerst geplaatst (Werkelijk)

23 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)