A Multicenter Study of Artificial Intelligence Model for Fetal Congenital Heart Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Congenital Heart Disease (CHD), Artificial Intelligence (AI). Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Beijing Anzhen Hospital
Overview
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.
Primary outcome measures
- Diagnostic efficiency of AI model for fetal CHD [Time frame: From enrollment to diagnostic verification, the evaluation period should not exceed 12 month.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
China · 1 center
- Beijing Anzhen Hospital affiliated to Capital Medical University — Beijing
Identifiers
NCT: NCT06796127 · FCHD-MCS-02