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Active, Not Recruiting

NCT Number: NCT06783933

Artificial Intelligence-assisted Diagnosis

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Congenital Heart Disease (CHD) Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Structural Heart Disease

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai hospital

Beijing, Beijing Municipality, 100037, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chest X-ray of patients with ASD;
  • Chest X-ray of patients with VSD;
  • Chest X-ray of patients with PDA;
  • Chest X-ray of patients with PFO;
  • Chest X-ray of patients with PS;
  • Chest X-ray of patients with TOF/PAA;
  • Chest X-ray of patients with MS;
  • Chest X-ray of patients with other heart diseases;

Exclusion criteria

  • CHD Patients without surgical, interventional validation;
  • Serious Scoliosis;
  • Pulmonary inflammation or consolidation

Treatment and study plan

surgical or interventional validation

Diagnostic Test

surgical or interventional validation

Primary outcomes

  1. accuracy with AI-assisted diagnosis

    Time frame: 12 months

    Number of subjects with accuracy of CHD ; based on surgical validation or interventional validation.

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Collaborators

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

Registry information

Official study title

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

Acronym: AID

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jan 20, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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