Congenital Heart Disease (CHD)AIDNCT06783933
Artificial Intelligence-assisted Diagnosis
An observational study of Congenital Heart Disease (CHD) and Structural Heart Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This study aims to investigate whether an AI-assisted decision support can improve the diagnosis of congenital heart diseases on Chest X-ray. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease (CHD), Structural Heart Disease
- What is being tested?
- surgical or interventional validation
- How many people
- 60,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2025to 15 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study will enroll subjects with CHD and structural heart diseases.
Who may be able to join
- 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;
Who cannot join
- CHD Patients without surgical, interventional validation;
- Serious Scoliosis;
- Pulmonary inflammation or consolidation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- surgical or interventional validation
- Keywords
- artificial intelligence；congenital heart diseases；Chest X-ray；diagnosis
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical or interventional validationDiagnostic test
surgical or interventional validation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: surgical or interventional validation |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy with AI-assisted diagnosis
Number of subjects with accuracy of CHD ; based on surgical validation or interventional validation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start15 Jan 2025
- Primary completion15 Jan 2030 (estimated)
- Study completion15 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Collaborators
- Beijing Anzhen Hospital, Nanjing Medical University, Shanghai Jiao Tong University School of Medicine, Capital Medical University, Sichuan University, Kunming Medical University, Anhui Medical University, Shandong University, Zhejiang University, Peking Union Medical College, Harbin Medical University, Xi'an Jiaotong University, Huazhong University of Science and Technology, Guangdong Provincial People's Hospital, Wuhan University, Central South University, Chinese Academy of Sciences, The First Hospital of Hebei Medical University, Handan First Hospital, Second Affiliated Hospital of Wenzhou Medical University, Anyang Maternal and Child Health Care Center, Wenzhou Medical University, Guangxi Medical University, Xinjiang Medical University, Chongqing General Hospital, Tibet Autonomous Region People's Hospital, The Affiliated Hospital of Zunyi Medical College, Second Affiliated Hospital of Nanchang University, Second Xiangya Hospital of Central South University, Second Hospital of Shanxi Medical University, Handan Central Hospital, Affiliated First Hospital of Ningxia Medical University, Chinese Academy of Medical Sciences, Fuwai Hospital, Xijing Hospital, Inner Mongolia People's Hospital, Qinghai province cardiovascular and cerebrovascular disease specialist hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, China Medical University, China, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Qilu Hospital of Shandong University, Tianjin Medical University General Hospital, Hainan General Hospital, Fujian Medical University, Lanzhou University Second Hospital, Second Hospital of Jilin University, Zunyi Medical College, Ningxia Medical University, LanZhou University, Jilin University, West China Hospital, Peking University, Fudan University, Ruijin Hospital, Zhengzhou University
- Responsible party
- Sponsor
- Investigators
- Shihua Zhao, MD and PhD, Study chair, Fuwai Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783933
- Sponsor's protocol ID
- 2020-4
- Other IDs
- 2021YFF0501400
- Acronym
- AID
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-assisted Diagnosis of Congenital Heart Diseases on Chest X-ray
- ClinicalTrials.gov ID
- NCT06783933
- Acronym / sponsor ID
- AID / 2020-4
- Keywords
- artificial intelligence；congenital heart diseases；Chest X-ray；diagnosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60,000 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Beijing Anzhen Hospital, Nanjing Medical University, Shanghai Jiao Tong University School of Medicine, Capital Medical University, Sichuan University, Kunming Medical University, Anhui Medical University, Shandong University, Zhejiang University, Peking Union Medical College, Harbin Medical University, Xi'an Jiaotong University, Huazhong University of Science and Technology, Guangdong Provincial People's Hospital, Wuhan University, Central South University, Chinese Academy of Sciences, The First Hospital of Hebei Medical University, Handan First Hospital, Second Affiliated Hospital of Wenzhou Medical University, Anyang Maternal and Child Health Care Center, Wenzhou Medical University, Guangxi Medical University, Xinjiang Medical University, Chongqing General Hospital, Tibet Autonomous Region People's Hospital, The Affiliated Hospital of Zunyi Medical College, Second Affiliated Hospital of Nanchang University, Second Xiangya Hospital of Central South University, Second Hospital of Shanxi Medical University, Handan Central Hospital, Affiliated First Hospital of Ningxia Medical University, Chinese Academy of Medical Sciences, Fuwai Hospital, Xijing Hospital, Inner Mongolia People's Hospital, Qinghai province cardiovascular and cerebrovascular disease specialist hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, China Medical University, China, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Qilu Hospital of Shandong University, Tianjin Medical University General Hospital, Hainan General Hospital, Fujian Medical University, Lanzhou University Second Hospital, Second Hospital of Jilin University, Zunyi Medical College, Ningxia Medical University, LanZhou University, Jilin University, West China Hospital, Peking University, Fudan University, Ruijin Hospital, Zhengzhou University
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Jan 2030 (estimated)
- Study completion
- 15 Jan 2030 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previous data of chest X-ray in patients with CHD | – | Diagnostic Test: surgical or interventional validationPhase 1: Previous data of chest X-ray in patients with CHD. A minimum of 5000 patients is reached. |
| Prospective inclusion of general patients with chest X-ray | – | Diagnostic Test: surgical or interventional validationProspective inclusion of general patients with chest X-ray. A minimum of 50000 patients is reached. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will enroll subjects with CHD and structural heart diseases.
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (3 listed)
- CHD Patients without surgical, interventional validation;
- Serious Scoliosis;
- Pulmonary inflammation or consolidation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical or interventional validationsurgical or interventional validation | Diagnostic test | Previous data of chest X-ray in patients with CHD, Prospective inclusion of general patients with chest X-ray |
Primary outcome
accuracy with AI-assisted diagnosis
Time frame: 12 months
Number of subjects with accuracy of CHD ; based on surgical validation or interventional validation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shihua Zhao, MD and PhD study chair
Fuwai Hospital, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease (CHD) and Structural Heart Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy with AI-assisted diagnosis (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.