NCT06783933

Artificial Intelligence-assisted Diagnosis

Artificial Intelligence-assisted Diagnosis of Congenital Heart Diseases on Chest X-ray

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60,000 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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 5000 patients is reached. Phase 2: Prospective inclusion of general patients with chest X-ray. A minimum of 50000 patients is reached.

Conditions

• Congenital Heart Disease (CHD)
• Structural Heart Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	surgical or interventional validation	surgical or interventional validation

Timeline

• Start date: 2025-01-15
• Primary completion: 2030-01-15
• Completion: 2030-01-15
• First posted: 2025-01-20
• Last updated: 2025-07-14

Locations

1 site across 1 country: China