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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05961748
Other study ID # KY2022-221-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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