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

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Capital Medical University

Status

Not yet enrolling

Conditions

Congenital Heart Disease (CHD)
Artificial Intelligence (AI)

Study type

Observational

Funder types

Other

Identifiers

NCT06796127
FCHD-MCS-02

Details and patient eligibility

About

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.

Enrollment

10,000 estimated patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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