Artificial Intelligence-assisted Diagnosis (AID)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Structural Heart Disease; Congenital Heart Disease (CHD)
• Intervention / Treatment: Diagnostic test: surgical or interventional validation

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.

• Study Type: Observational
• Enrollment (Estimated): 60000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Fuwai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; surgical or interventional validation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
accuracy with AI-assisted diagnosis	Number of subjects with accuracy of CHD ; based on surgical validation or interventional validation.	12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Estimated): January 15, 2030
• Study Completion (Estimated): January 15, 2030

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: artificial intelligence；congenital heart diseases；Chest X-ray；diagnosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 2020-4; 2021YFF0501400 (Other Identifier: Ministry of Science and Technology)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data that support the findings of this study are available from the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No