A Comprehensive Registry Study of the Whole Life Cycle of Patients With CHD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Congenital Heart Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Comprehensive Registry Study of the Whole Life Cycle of Patients With Congenital Heart Diseases
Overview
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.
Primary outcome measures
- The mortality of the first week after surgery [Time frame: Duration of hospital stay (an expected average of 1 week)]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- Patients with various congenital heart diseases
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Beijing AnZhen Hospital — Beijing
Identifiers
NCT: NCT06611787 · AZ 2024 No. (1) RSTE