Clinical trial NCT05961748: Registry of Multicenter Brain-Heart Comorbidity in China
Official title: Registry of Multicenter Brain-Heart Comorbidity in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Heart Disease
Cardiac Arrest
Atrial Fibrillation
Heart Failure
Aortic Diseases
Subarachnoid Hemorrhage
Intracerebral Hemorrhage
Cerebral Infarction
Occlusion and Stenosis of Precerebral Arteries
Occlusion and Stenosis of Cerebellar Arteries
Cerebral Aneurysm
Moyamoya Disease
Arteriovenous Malformation of Cerebral Vessels
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Rate of Participants with Composite of All-Cause Mortality and Cardiovascular Outcomes
timeFrame: At discharge/30 days
measure: All-Cause Mortality
timeFrame: At discharge/30 days
measure: Rate of Participants with Composite of Cardiovascular Outcomes
timeFrame: At discharge/30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Chinese People's Liberation Army (PLA) General Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Shenzhen
country: China
facility: Shenzhen Qianhai Shekou Free Trade Zone Hospital
state: Guangdong
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Shanghai
country: China
facility: Huashan Hospital of Fudan University
state: Shanghai
city: Shanxi
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
affiliation: Beijing Tiantan Hospital
name: Shuo Wang, MD
role: STUDY_CHAIR
affiliation: Beijing Tiantan Hospital
name: Yong Cao, MD
role: STUDY_DIRECTOR
affiliation: Beijing Tiantan Hospital
name: Dong Xu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Zening Jin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Hao Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Shuai Kang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Yu Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Qingyuan Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Runting Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Heze Han, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Wenxiong Song, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Jionghao Xue, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Minghao Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: