An observational study in Congenital Heart Disease, sponsored by Beijing Anzhen Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by Beijing Anzhen Hospital · Observational
This observational study aims to collect data on the prevalence, intervention, and prognosis of congenital heart disease (CHD) in Chinese patients across their entire lifecycle. From the diagnosis of CHD in fetuses, to early treatment of severe CHD in neonates, to standardized perinatal diagnosis and treatment of CHD patients with concurrent pregnancy, the study employs a cyclical model consisting of evaluation, training, improvement, and re-evaluation. The goal is to enhance the diagnostic and treatment capabilities of participating hospitals, especially for complex CHD cases, and promote standardized clinical practices in cardiovascular disease treatment among these hospitals. This will ultimately improve the quality of medical services provided to cardiovascular patients and serve as a basis for exploring CHD treatment guidelines suitable for China.
The project will be implemented by Capital Medical University Affiliated Beijing Anzhen Hospital and the National Clinical Research Center for Cardiovascular Diseases. The plan is to involve more than 20 hospitals over the next five years. An independent website will be created for data collection, education and training, as well as experience sharing among participating hospitals. Starting from January 1, 2024, each hospital will continuously collect CHD inpatient cases on a monthly basis. The project team will regularly analyze and report on the completion of key medical quality evaluation indicators for each hospital. They will provide guidance measures such as education, training, experience sharing, and on-site investigations to address identified issues, helping hospitals improve medical quality. Hospitals that demonstrate excellence and significant improvement will be recognized and commended, driving overall improvement in the quality of cardiovascular medical care in China.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 100,000 is above the median of 294 across 1,241 observational studies indexed under Heart Diseases.
Browse Heart Diseases studies →Beijing Anzhen Hospital is the lead sponsor of 188 studies on the registry; 100 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with various congenital heart diseases.
Exclusion Criteria:
The mortality of the first week after surgery
Intraoperative surgeries encompass a broad range of procedures performed during a surgical operation, often involving complex and high-risk interventions. In terms of in-hospital mortality within 1 weeks after surgery, the risk associated with intraoperative surgeries can be elevated due to factors, the complexity of the procedure, and potential complications. Routine neonatal surgeries, on the other hand, are procedures commonly performed on newborns, often to address congenital anomalies or other medical conditions present at birth. While these surgeries are generally considered safer than more complex intraoperative procedures, there is still a risk of in-hospital mortality within 1 week after surgery, particularly for neonates with pre-existing health issues or complications during the surgical process. Close monitoring and prompt intervention are crucial to minimize this risk and ensure the best possible outcomes for neonatal patients
Time frame: Duration of hospital stay (an expected average of 1 week)
The ratio of newborns receiving integrated prenatal and postnatal diagnosis and treatment;
Time frame: Duration of hospital stay (an expected average of 1 week) and 5 years after discharge
The ratio of intraoperative surgeries among all neonatal surgeries;
Time frame: Duration of hospital stay (an expected average of 1 week) and 5 years after discharge
The rate of Medium- and long-term survival rates, and re-operations
Time frame: Duration of hospital stay (an expected average of 1 week) and 5 years after discharge
Plan to share: No
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Beijing Anzhen Hospital