Registry of Multicenter Brain-Heart Comorbidity in China

Heart Failure Clinical Trial

— BHC-C  

Official title:

Registry of Multicenter Brain-Heart Comorbidity in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05961748
• Other study ID #: KY2022-221-02
• Status: Recruiting
• Start date: January 1, 2012
• Est. completion date: December 31, 2032

Study information

• Verified date: September 2023
• Source: Beijing Tiantan Hospital
• Contact: Xiaolin Chen, MD
• Phone: 13810624845
• Email: cxl_bjtth[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a multi-center, prospective, registry study. This research was supported by the National Key Research and Development Program. To establish a domestic multi-center, large-scale "brain-heart comorbidity" dynamic database platform including clinical, sample database, image and other multi-dimensional information requirements, through the construction of a multi-center intelligent scientific research integration platform based on artificial intelligence.

Any of newly diagnosed cardiovascular related diseases were identified via ICD-10-CM codes:

I21, I22, I24 (Ischaemic heart diseases) [i.e., ACS], I46 (cardiac arrest), I48 (Atrial fibrillation/flutter), I50 (Heart failure), I71 (Aortic disease), I60 (subarachnoid hemorrhage), I61 (intracerebral hemorrhage), I63 (Cerebral infarction), I65 (Occlusion and stenosis of precerebral arteries), I66 (Occlusion and stenosis of cerebral arteries), I67.1 (cerebral aneurysm), I67.5 (moyamoya diseases), Q28.2 (Arteriovenous malformation of cerebral vessels).

The data is stored on the brain-heart comorbidity warehouse via a physical server at the institution's data centre or a virtual hosted appliance. The brain-heart comorbidity platform comprises of a series of these appliances connected into a multicenter network. This network can broadcast queries to each appliance. Results are subsequently collected and aggregated. Once the data is sent to the network, it is mapped to a standard and controlled set of clinical terminologies and undergoes a data quality assessment including 'data cleaning' that rejects records which do not meet the brain-heart comorbidity quality standards. The brain-heart comorbidity warehouse performs internal and extensive data quality assessment with every refresh based on conformance, completeness, and plausibility (http://10.100.101.65:30080/login).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: December 31, 2032
• Est. primary completion date: December 31, 2032
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18 years old

• Any of newly diagnosed cardiovascular-related diseases were identified via ICD-10-CM codes: I21, I22, I24 (Ischaemic heart diseases) [i.e., ACS], I46 (cardiac arrest), I48 (Atrial fibrillation/flutter), I50 (Heart failure), I71 (Aortic disease), I60 (subarachnoid hemorrhage), I61 (intracerebral hemorrhage), I63 (Cerebral infarction), I65 (Occlusion and stenosis of precerebral arteries), I66 (Occlusion and stenosis of cerebral arteries), I67.1 (cerebral aneurysm), I67.5 (moyamoya diseases), Q28.2 (Arteriovenous malformation of cerebral vessels).

Exclusion Criteria:

·refuse to participate in the registry

Related Conditions & MeSH terms

• Aortic Diseases
• Arteriovenous Malformations
• Atrial Fibrillation
• Cardiac Arrest
• Cerebral Aneurysm
• Cerebral Hemorrhage
• Cerebral Infarction
• Constriction, Pathologic
• Coronary Artery Disease
• Heart Failure
• Hemorrhage
• Intracerebral Hemorrhage
• Intracranial Aneurysm
• Ischemic Heart Disease
• Moyamoya Disease
• Myocardial Ischemia
• Subarachnoid Hemorrhage

Intervention

Other:
• Multi-disciplinary assessment
Multi-disciplinary assessment

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing
China	Chinese People's Liberation Army (PLA) General Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	The First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Second Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Huashan Hospital of Fudan University	Shanghai	Shanghai
China	Shanxi Provincial People's Hospital	Shanxi	Shanxi
China	Shenzhen Qianhai Shekou Free Trade Zone Hospital	Shenzhen	Guangdong
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Participants with Composite of All-Cause Mortality and Cardiovascular Outcomes	The occurrence of all-cause mortality, coronary artery disease event, stroke (ischemic or hemorrhagic), heart failure, or atrial fibrillation etc.	At discharge/30 days
Primary	All-Cause Mortality	The occurrence of death	At discharge/30 days
Primary	Rate of Participants with Composite of Cardiovascular Outcomes	The occurrence of coronary artery disease event, stroke (ischemic or hemorrhagic), heart failure, or atrial fibrillation etc.	At discharge/30 days