Clinical trial NCT06611787: A Comprehensive Registry Study of the Whole Life Cycle of Patients With CHD
Official title: A Comprehensive Registry Study of the Whole Life Cycle of Patients With Congenital Heart Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Heart Disease
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with various congenital heart diseases.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients with various congenital heart diseases

Exclusion Criteria:

* None

Primary outcomes:
measure: The mortality of the first week after surgery
timeFrame: Duration of hospital stay (an expected average of 1 week)
Secondary outcomes:
measure: The ratio of newborns receiving integrated prenatal and postnatal diagnosis and treatment;
timeFrame: Duration of hospital stay (an expected average of 1 week) and 5 years after discharge
measure: The ratio of intraoperative surgeries among all neonatal surgeries;
timeFrame: Duration of hospital stay (an expected average of 1 week) and 5 years after discharge
measure: The rate of Medium- and long-term survival rates, and re-operations
timeFrame: Duration of hospital stay (an expected average of 1 week) and 5 years after discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing AnZhen Hospital
state: Beijing
Study officials:
References: