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

NCT ID: NCT06796127

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2026-08-01

Brief 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.

Conditions

Congenital Heart Disease (CHD); Artificial Intelligence (AI)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Anzhen Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

FCHD-MCS-02

Identifier Type: -

Identifier Source: org_study_id