Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-01 @ 5:17 AM
Study NCT ID:
NCT06783933
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-14
First Post:
2025-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Artificial Intelligence-assisted Diagnosis
Sponsor:
China National Center for Cardiovascular Diseases
Organization:
Study Overview
Official Title:
Artificial Intelligence-assisted Diagnosis of Congenital Heart Diseases on Chest X-ray
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AID
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 5000 patients is reached.
Phase 2: Prospective inclusion of general patients with chest X-ray. A minimum of 50000 patients is reached.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021YFF0501400 | OTHER | Ministry of Science and Technology | View |