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

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.

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Key information

Conditions

Congenital Heart Disease (CHD) Artificial Intelligence (AI) Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Beijing Anzhen Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, 100010, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Diagnostic efficiency of AI model for fetal CHD

Time frame: From enrollment to diagnostic verification, the evaluation period should not exceed 12 month.

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study title

Beijing Anzhen Hospital

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jan 28, 2025
Registry last updated: Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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