Congenital Heart DiseaseNCT06611787
A Comprehensive Registry Study of the Whole Life Cycle of Patients With CHD
An observational study of Congenital Heart Disease, run by Beijing Anzhen Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 100,000 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2024to 1 Jan 2030
- How long will I take part?
- 30 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with various congenital heart diseases.
Who may be able to join
- Patients with various congenital heart diseases
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qiang Wang, MD contact
China1 site, 1 recruiting
- Recruiting
Beijing AnZhen Hospital
Beijing, Beijing Municipality, 100000
JiaChen Li, MD, 18513494314 ext. +86, lijiachen0915@126.com
About this study
Official title: A Comprehensive Registry Study of the Whole Life Cycle of Patients With Congenital Heart Diseases
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.
- Conditions
- Congenital Heart Disease
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Duration of hospital stay (an expected average of 1 week)
Secondary outcomes (3)
The ratio of newborns receiving integrated prenatal and postnatal diagnosis and treatment;
Measured: Duration of hospital stay (an expected average of 1 week) and 5 years after discharge
The ratio of intraoperative surgeries among all neonatal surgeries;
Measured: 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
Measured: Duration of hospital stay (an expected average of 1 week) and 5 years after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start2 Feb 2024
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100,000 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611787
- Sponsor's protocol ID
- AZ 2024 No. (1) RSTE
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Registry Study of the Whole Life Cycle of Patients With Congenital Heart Diseases
- ClinicalTrials.gov ID
- NCT06611787
- Acronym / sponsor ID
- AZ 2024 No. (1) RSTE
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 30 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with various congenital heart diseases.
Key inclusion criteria (1 listed)
- Patients with various congenital heart diseases
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The mortality of the first week after surgery
Time frame: Duration of hospital stay (an expected average of 1 week)
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qiang Wang, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JiaChen Li, MD (18513494314 ext. +86, lijiachen0915@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mortality of the first week after surgery (time frame: Duration of hospital stay (an expected average of 1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.