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

January 26, 2025 updated by: Beijing Anzhen Hospital

Beijing Anzhen Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100010
        • Beijing Anzhen Hospital Affiliated to Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic efficiency of AI model for fetal CHD
Time Frame: From enrollment to diagnostic verification, the evaluation period should not exceed 12 month.
From enrollment to diagnostic verification, the evaluation period should not exceed 12 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

January 20, 2025

First Submitted That Met QC Criteria

January 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 26, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FCHD-MCS-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Congenital Heart Disease (CHD)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe