A Multicenter Study of Artificial Intelligence Model for Fetal Congenital Heart Disease

NCT06796127 · tracked via the Priya Life Science China tracker

Sponsor

Beijing Anzhen Hospital

Phase

Observational

Started

2025-02-01

Last updated

2025-01-28

Condition(s) studied

Congenital Heart Disease (CHD)Artificial Intelligence (AI)

Study summary

This study addresses congenital heart disease in fetuses, a specific birth defect, by collaborating with multicenter medical institutions across China. It prospectively collects echocardiographic screening, diagnostic images, and structured parameter data from both normal and abnormal fetuses. Cases are followed up, and artificial intelligence (AI) models are developed to extract fetal heart echocardiographic image features and analyze the data. This process allows for the analysis of the AI models' accuracy, sensitivity, and specificity, and verifies the application value of AI models in fetal heart echocardiographic screening and diagnosis.

Eligibility

Sex

FEMALE

Min age

—

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: * Single or multiple pregnancy; * Gestational age 16-40 weeks; * Fetal echocardiographic images are clear and complete; * Clinical data are complete and detailed; * Sign informed consent and be able to cooperate with follow-up Exclusion Criteria: * Fetal echocardiographic images are incomplete or of poor quality that cannot be used for research; * Refusal or loss of follow-up

Primary outcome measure(s)

Diagnostic efficiency of AI model for fetal CHD — From enrollment to diagnostic verification, the evaluation period should not exceed 12 month.

Trial sites (1)

Facility	City	Region	Status
Beijing Anzhen Hospital affiliated to Capital Medical University	Beijing	Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06796127 on ClinicalTrials.gov ↗ ← All trials in China