Active — Not RecruitingNot Applicable

Early Warning of Structural Complications in Perimembranous VSD

China11,683 participantsStarted 2004-01-01

Plain-language summary

The goal of this observational study is to develop and test a AI-based prediction model for children with perimembranous ventricular septal defect, also called PMVSD. PMVSD is a type of hole between the lower chambers of the heart. Some children with PMVSD may later develop heart structure problems, such as aortic valve prolapse or leakage, subaortic fibrous ridge, left ventricle-to-right atrium shunt, or right ventricular outflow tract obstruction. This study will use past medical records and echocardiography reports from children who received care at six hospitals in China between 2004 and 2022. The main questions it aims to answer are: Can information written in echocardiography reports help predict which children with PMVSD are more likely to develop heart structure problems? Can natural language processing and machine learning improve early risk prediction when used together with routine clinical information? Researchers will review existing, de-identified medical data. They will use natural language processing to turn written descriptions in echocardiography reports into data that a computer model can analyze. These descriptions may include details about the edge of the heart defect, the direction of blood flow, and the relationship between the defect and nearby heart valves. Participants will not receive any study treatment or extra tests. The study will only use information already collected during routine medical care. The prediction models will be trained and tested using data from different hospitals to see how well they work across medical centers.

Who can participate

Age range

0 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children aged 14 years or younger at the time of presentation/diagnosis; * Confirmed diagnosis of perimembranous ventricular septal defect (PMVSD), or PMVSD accompanied by minor cardiac anomalies that do not alter the hemodynamic status of the VSD, including small patent foramen ovale, atrial septal defect, patent ductus arteriosus, or persistent left superior vena cava; * Availability of at least two consecutive follow-up records, with consistency between the electronic echocardiography reports and the Hospital Information System data. Exclusion Criteria: * Age older than 14 years at diagnosis; * Presence of complex congenital heart disease; * Patients lost to follow-up due to inability to establish contact, resulting in an indeterminate clinical outcome.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Occurrence of Perimembranous Ventricular Septal Defect Related Structural Complications

Timeframe: From initial diagnosis through 3 years after diagnosis

Trial details

NCT IDNCT07662343

SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-01-01

View on ClinicalTrials.gov More Congenital Heart Disease (CHD) trials