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Artificial Intelligence-assisted Diagnosis

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06783933
Acronym
AID
Enrollment
60000
Registered
2025-01-20
Start date
2025-01-15
Completion date
2030-01-15
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease (CHD), Structural Heart Disease

Keywords

artificial intelligence;congenital heart diseases;Chest X-ray;diagnosis

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.

Interventions

DIAGNOSTIC_TESTsurgical or interventional validation

surgical or interventional validation

Sponsors

Beijing Anzhen Hospital
CollaboratorOTHER
Nanjing Medical University
CollaboratorOTHER
Shanghai Jiao Tong University School of Medicine
CollaboratorOTHER
Capital Medical University
CollaboratorOTHER
Sichuan University
CollaboratorOTHER
Kunming Medical University
CollaboratorOTHER
Anhui Medical University
CollaboratorOTHER
Shandong University
CollaboratorOTHER
Zhejiang University
CollaboratorOTHER
Peking Union Medical College
CollaboratorOTHER
Harbin Medical University
CollaboratorOTHER
Xi'an Jiaotong University
CollaboratorOTHER
Huazhong University of Science and Technology
CollaboratorOTHER
Guangdong Provincial People's Hospital
CollaboratorOTHER
Wuhan University
CollaboratorOTHER
Central South University
CollaboratorOTHER
University of Chinese Academy of Sciences
CollaboratorUNKNOWN
The First Hospital of Hebei Medical University
CollaboratorOTHER
Handan First Hospital
CollaboratorOTHER
Second Affiliated Hospital of Wenzhou Medical University
CollaboratorOTHER
Anyang Maternal and Child Health Care Center
CollaboratorUNKNOWN
Wenzhou Medical University
CollaboratorOTHER
Guangxi Medical University
CollaboratorOTHER
Xinjiang Medical University
CollaboratorOTHER
Chongqing General Hospital
CollaboratorOTHER
Tibet Autonomous Region People's Hospital
CollaboratorOTHER
The Affiliated Hospital of Zunyi Medical College
CollaboratorUNKNOWN
Second Affiliated Hospital of Nanchang University
CollaboratorOTHER
Second Xiangya Hospital of Central South University
CollaboratorOTHER
Second Hospital of Shanxi Medical University
CollaboratorOTHER
Handan Central Hospital
CollaboratorOTHER
Affiliated First Hospital of Ningxia Medical University
CollaboratorUNKNOWN
Chinese Academy of Medical Sciences, Fuwai Hospital
CollaboratorOTHER
Xijing Hospital
CollaboratorOTHER
Inner Mongolia People's Hospital
CollaboratorOTHER
Qinghai province cardiovascular and cerebrovascular disease specialist hospital
CollaboratorUNKNOWN
Second Affiliated Hospital, School of Medicine, Zhejiang University
CollaboratorOTHER
China Medical University, China
CollaboratorOTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
CollaboratorOTHER
Qilu Hospital of Shandong University
CollaboratorOTHER
Tianjin Medical University General Hospital
CollaboratorOTHER
Hainan General Hospital
CollaboratorOTHER
Fujian Medical University
CollaboratorOTHER
Lanzhou University Second Hospital
CollaboratorOTHER
Second Hospital of Jilin University
CollaboratorOTHER
Zunyi Medical College
CollaboratorOTHER
Ningxia Medical University
CollaboratorOTHER
LanZhou University
CollaboratorOTHER
Jilin University
CollaboratorOTHER
West China Hospital
CollaboratorOTHER
Peking University
CollaboratorOTHER
Fudan University
CollaboratorOTHER
Ruijin Hospital
CollaboratorOTHER
Zhengzhou University
CollaboratorOTHER
China National Center for Cardiovascular Diseases
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
accuracy with AI-assisted diagnosis12 monthsNumber of subjects with accuracy of CHD ; based on surgical validation or interventional validation.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026