Congenital Heart Disease (CHD)NCT06796127
A Multicenter Study of Artificial Intelligence Model for Fetal Congenital Heart Disease
An observational study of Congenital Heart Disease (CHD) and Artificial Intelligence (AI), run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
This study addresses congenital heart disease in fetuses, a specific birth defect, by collaborating with multicenter medical institutions across China. It prospectively collects echocardiographic screening, diagnostic images, and structured parameter data from both normal and abnormal fetuses. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease (CHD), Artificial Intelligence (AI)
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 1 Aug 2026
- How long will I take part?
- 1 Year
- 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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population was from 20 multi-center medical institutions in China, and pregnant women who underwent fetal echocardiography between 16 and 40 weeks of gestation.
Who may be able to join
- Single or multiple pregnancy;
- Gestational age 16-40 weeks;
- Fetal echocardiographic images are clear and complete;
- Clinical data are complete and detailed;
- Sign informed consent and be able to cooperate with follow-up
Who cannot join
- Fetal echocardiographic images are incomplete or of poor quality that cannot be used for research;
- Refusal or loss of follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Anzhen Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 100010
About this study
Official title: Beijing Anzhen Hospital
This study addresses congenital heart disease in fetuses, a specific birth defect, by collaborating with multicenter medical institutions across China. It prospectively collects echocardiographic screening, diagnostic images, and structured parameter data from both normal and abnormal fetuses. Cases are followed up, and artificial intelligence (AI) models are developed to extract fetal heart echocardiographic image features and analyze the data. This process allows for the analysis of the AI models' accuracy, sensitivity, and specificity, and verifies the application value of AI models in fetal heart echocardiographic screening and diagnosis.
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic efficiency of AI model for fetal CHD
Measured: From enrollment to diagnostic verification, the evaluation period should not exceed 12 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Aug 2026 (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
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796127
- Sponsor's protocol ID
- FCHD-MCS-02
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beijing Anzhen Hospital
- ClinicalTrials.gov ID
- NCT06796127
- Acronym / sponsor ID
- FCHD-MCS-02
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 28 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 addresses congenital heart disease in fetuses, a specific birth defect, by collaborating with multicenter medical institutions across China. It prospectively collects echocardiographic screening, diagnostic images, and structured parameter data from both normal and abnormal fetuses. Cases are followed up, and artificial intelligence (AI) models are developed to extract fetal heart echocardiographic image features and analyze the data. This process allows for the analysis of the AI models' accuracy, sensitivity, and specificity, and verifies the application value of AI models in fetal heart echocardiographic screening and diagnosis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population was from 20 multi-center medical institutions in China, and pregnant women who underwent fetal echocardiography between 16 and 40 weeks of gestation.
Key inclusion criteria (5 listed)
- Single or multiple pregnancy;
- Gestational age 16-40 weeks;
- Fetal echocardiographic images are clear and complete;
- Clinical data are complete and detailed;
- Sign informed consent and be able to cooperate with follow-up
Key exclusion criteria (2 listed)
- Fetal echocardiographic images are incomplete or of poor quality that cannot be used for research;
- Refusal or loss of follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic efficiency of AI model for fetal CHD
Time frame: From enrollment to diagnostic verification, the evaluation period should not exceed 12 month.
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 28 Jan 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Artificial Intelligence (AI), run by Beijing Anzhen Hospital 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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 28 Jan 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?
Diagnostic efficiency of AI model for fetal CHD (time frame: From enrollment to diagnostic verification, the evaluation period should not exceed 12 month.). 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 28 Jan 2025.