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
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