Artificial Intelligence-assisted Diagnosis

Active, not recruiting

• Conditions: Congenital Heart Disease (CHD); Structural Heart Disease

• Registration Number: NCT06783933
• Lead Sponsor: China National Center for Cardiovascular Diseases

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.

Detailed Description

Congenital heart disease (CHD) is a structural abnormality of the heart and/or great vessels and the frequency of CHD is nearly 1% in general population. In clinical practice, Chest X-ray is an important routine method for detection of CHD. However, its learning curve is high. Based on Chest X-ray, Artificial intelligence (AI) has the potential to improve the efficiency and accuracy of CHD. This study aims to investigate whether an AI-assisted decision support can improve the diagnosis of congenital heart diseases on Chest X-ray.

This study will enroll subjects with CHD, and the enrollment will be divided into two phases.

Phase 1: Previous data of chest X-ray in patients with CHD. A minimum of 3000 patients is reached.

Phase 2: Prospective inclusion of general patients with chest X-ray. A minimum of 5000 patients is reached.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-15
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-15
• Last Update Submitted: 2025-01-15
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20
• Primary Completion: 2026-01-15
• Study Completion: 2026-01-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 8000

Inclusion Criteria

1. Chest X-ray of patients with ASD;
2. Chest X-ray of patients with VSD;
3. Chest X-ray of patients with PDA;
4. Chest X-ray of patients with PFO;
5. Chest X-ray of patients with PS;
6. Chest X-ray of patients with TOF/PAA;
7. Chest X-ray of patients with MS;
8. Chest X-ray of patients with other heart diseases;

Exclusion Criteria

1. CHD Patients without surgical, interventional validation;
2. Serious Scoliosis;
3. Pulmonary inflammation or consolidation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
accuracy with AI-assisted diagnosis	12 months	Number of subjects with accuracy of CHD ; based on surgical validation or interventional validation.

Trial Locations

Locations (1)

Fuwai hospital; 🇨🇳 Beijing, Beijing, China