Artificial Intelligence-assisted Diagnosis

NCT ID: NCT06783933

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

60000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-15

Study Completion Date

2030-01-15

Brief Summary

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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

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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

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Congenital Heart Disease (CHD) Structural Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

surgical or interventional validation

Intervention Type DIAGNOSTIC_TEST

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.

surgical or interventional validation

Intervention Type DIAGNOSTIC_TEST

surgical or interventional validation

Interventions

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surgical or interventional validation

surgical or interventional validation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Capital Medical University

OTHER

Sponsor Role collaborator

Sichuan University

OTHER

Sponsor Role collaborator

Kunming Medical University

OTHER

Sponsor Role collaborator

Anhui Medical University

OTHER

Sponsor Role collaborator

Shandong University

OTHER

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role collaborator

Peking Union Medical College

OTHER

Sponsor Role collaborator

Harbin Medical University

OTHER

Sponsor Role collaborator

Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role collaborator

Wuhan University

OTHER

Sponsor Role collaborator

Central South University

OTHER

Sponsor Role collaborator

University of Chinese Academy of Sciences

UNKNOWN

Sponsor Role collaborator

The First Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

Handan First Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Anyang Maternal and Child Health Care Center

UNKNOWN

Sponsor Role collaborator

Wenzhou Medical University

OTHER

Sponsor Role collaborator

Guangxi Medical University

OTHER

Sponsor Role collaborator

Xinjiang Medical University

OTHER

Sponsor Role collaborator

Chongqing General Hospital

OTHER

Sponsor Role collaborator

Tibet Autonomous Region People's Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Zunyi Medical College

UNKNOWN

Sponsor Role collaborator

Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Second Hospital of Shanxi Medical University

OTHER

Sponsor Role collaborator

Handan Central Hospital

OTHER

Sponsor Role collaborator

Affiliated First Hospital of Ningxia Medical University

UNKNOWN

Sponsor Role collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role collaborator

Xijing Hospital

OTHER

Sponsor Role collaborator

Inner Mongolia People's Hospital

OTHER

Sponsor Role collaborator

Qinghai province cardiovascular and cerebrovascular disease specialist hospital

UNKNOWN

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

China Medical University, China

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

Hainan General Hospital

OTHER

Sponsor Role collaborator

Fujian Medical University

OTHER

Sponsor Role collaborator

Lanzhou University Second Hospital

OTHER

Sponsor Role collaborator

Second Hospital of Jilin University

OTHER

Sponsor Role collaborator

Zunyi Medical College

OTHER

Sponsor Role collaborator

Ningxia Medical University

OTHER

Sponsor Role collaborator

LanZhou University

OTHER

Sponsor Role collaborator

Jilin University

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

Peking University

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

Zhengzhou University

OTHER

Sponsor Role collaborator

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shihua Zhao, MD and PhD

Role: STUDY_CHAIR

Fuwai Hospital, Beijing, China

Locations

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Fuwai hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2021YFF0501400

Identifier Type: OTHER

Identifier Source: secondary_id

2020-4

Identifier Type: -

Identifier Source: org_study_id

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