NCT06783933

Brief Summary

This study aims to investigate whether an AI-assisted decision support can improve the diagnosis of congenital heart diseases on Chest X-ray.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60,000

participants targeted

Target at P75+ for all trials

Timeline
46mo left

Started Jan 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Jan 2025Jan 2030

First Submitted

Initial submission to the registry

January 15, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2030

Last Updated

July 14, 2025

Status Verified

January 1, 2025

Enrollment Period

5 years

First QC Date

January 15, 2025

Last Update Submit

July 10, 2025

Conditions

Congenital Heart Disease (CHD)Structural Heart Disease

Keywords

artificial intelligenceï¼›congenital heart diseasesï¼›Chest X-rayï¼›diagnosis

Outcome Measures

Primary Outcomes (1)

  • accuracy with AI-assisted diagnosis

    Number of subjects with accuracy of CHD ; based on surgical validation or interventional validation.

    12 months

Study Arms (2)

Previous data of chest X-ray in patients with CHD

Phase 1: Previous data of chest X-ray in patients with CHD. A minimum of 5000 patients is reached.

Diagnostic Test: surgical or interventional validation

Prospective inclusion of general patients with chest X-ray

Prospective inclusion of general patients with chest X-ray. A minimum of 50000 patients is reached.

Diagnostic Test: surgical or interventional validation

Interventions

surgical or interventional validationDIAGNOSTIC_TEST

surgical or interventional validation

Previous data of chest X-ray in patients with CHDProspective inclusion of general patients with chest X-ray

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study will enroll subjects with CHD and structural heart diseases.

You may qualify if:

  • Chest X-ray of patients with ASD;
  • Chest X-ray of patients with VSD;
  • Chest X-ray of patients with PDA;
  • Chest X-ray of patients with PFO;
  • Chest X-ray of patients with PS;
  • Chest X-ray of patients with TOF/PAA;
  • Chest X-ray of patients with MS;
  • Chest X-ray of patients with other heart diseases;

You may not qualify if:

  • CHD Patients without surgical, interventional validation;
  • Serious Scoliosis;
  • Pulmonary inflammation or consolidation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai hospital

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Shihua Zhao, MD and PhD

    Fuwai Hospital, Beijing, China

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2025

First Posted

January 20, 2025

Study Start

January 15, 2025

Primary Completion (Estimated)

January 15, 2030

Study Completion (Estimated)

January 15, 2030

Last Updated

July 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Locations

CN(1)