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

NCT06796127 | Not Yet Recruiting

• 1 other identifier: FCHD-MCS-02
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Diagnostic efficiency of AI model for fetal CHD

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population was from 20 multi-center medical institutions in China, and pregnant women who underwent fetal echocardiography between 16 and 40 weeks of gestation.

You may qualify if:

• 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

You may not qualify if:

• Fetal echocardiographic images are incomplete or of poor quality that cannot be used for research;
• Refusal or loss of follow-up

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 28, 2025
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)