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Registry of Multicenter Brain-Heart Comorbidity in China (BHC-C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05961748
Recruitment Status : Recruiting
First Posted : July 27, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Xiaolin Chen, MD, Beijing Tiantan Hospital

Study Description
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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).


Condition or disease Intervention/treatment
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 Other: Multi-disciplinary assessment

Study Design
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Study Type : Observational
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry of Multicenter Brain-Heart Comorbidity in China
Actual Study Start Date : January 1, 2012
Estimated Primary Completion Date : December 31, 2032
Estimated Study Completion Date : December 31, 2032

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Multi-disciplinary assessment
    Multi-disciplinary assessment

Outcome Measures
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Primary Outcome Measures :
  1. Rate of Participants with Composite of All-Cause Mortality and Cardiovascular Outcomes [ Time Frame: At discharge/30 days ]
    The occurrence of all-cause mortality, coronary artery disease event, stroke (ischemic or hemorrhagic), heart failure, or atrial fibrillation etc.

  2. All-Cause Mortality [ Time Frame: At discharge/30 days ]
    The occurrence of death

  3. Rate of Participants with Composite of Cardiovascular Outcomes [ Time Frame: At discharge/30 days ]
    The occurrence of coronary artery disease event, stroke (ischemic or hemorrhagic), heart failure, or atrial fibrillation etc.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05961748


Contacts
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Contact: Xiaolin Chen, MD 13810624845 cxl_bjtth@163.com
Contact: Fa Lin, MD 13681107240 13681107240@163.com

Locations
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China, Beijing
Beijing Tiantan Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100070
Contact: Fa Lin, MD    13681107240    13681107240@163.com   
Beijing Anzhen Hospital, Capital Medical University Not yet recruiting
Beijing, Beijing, China
Contact: Ming Gong, MD         
Contact: Hai Gao, MD         
Beijing Chaoyang Hospital, Capital Medical University Not yet recruiting
Beijing, Beijing, China
Contact: Xiaojuan Guo, MD         
Chinese People's Liberation Army (PLA) General Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Hang Zhu, MD         
Peking University First Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Wei Ma, MD         
Contact: Xinggang Wang, MD         
Xuanwu Hospital, Capital Medical University Not yet recruiting
Beijing, Beijing, China
Contact: Yingqi Xing, MD         
China, Fujian
The First Affiliated Hospital of Fujian Medical University Not yet recruiting
Fuzhou, Fujian, China
Contact: Dezhi Kang, MD         
The First Affiliated Hospital of Xiamen University Not yet recruiting
Xiamen, Fujian, China
Contact: Sifang Chen, MD         
China, Guangdong
Shenzhen Qianhai Shekou Free Trade Zone Hospital Not yet recruiting
Shenzhen, Guangdong, China
Contact: Zhiwei Wang, MD         
China, Heilongjiang
The First Affiliated Hospital of Harbin Medical University Not yet recruiting
Harbin, Heilongjiang, China
Contact: Huaizhang Shi, MD         
China, Henan
The First Affiliated Hospital of Zhengzhou University Not yet recruiting
Zhengzhou, Henan, China
Contact: Dongming Yan, MD         
Contact: Guosheng Zhou, MD         
China, Shanghai
Huashan Hospital of Fudan University Not yet recruiting
Shanghai, Shanghai, China
Contact: Bin Xu, MD         
Contact: Feng Xu, MD         
China, Shanxi
Shanxi Provincial People's Hospital Not yet recruiting
Shanxi, Shanxi, China
Contact: Shaohua Ren, MD         
China, Yunnan
The Second Affiliated Hospital of Kunming Medical University Not yet recruiting
Kunming, Yunnan, China
Contact: Jun Pu, MD         
Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
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Study Chair: Shuo Wang, MD Beijing Tiantan Hospital
Study Director: Yong Cao, MD Beijing Tiantan Hospital
Principal Investigator: Dong Xu, MD Beijing Tiantan Hospital
Principal Investigator: Zening Jin, MD Beijing Tiantan Hospital
Principal Investigator: Hao Wang, MD Beijing Tiantan Hospital
Principal Investigator: Shuai Kang, MD Beijing Tiantan Hospital
Principal Investigator: Yu Chen, MD Beijing Tiantan Hospital
Principal Investigator: Qingyuan Liu, MD Beijing Tiantan Hospital
Principal Investigator: Runting Li, MD Beijing Tiantan Hospital
Principal Investigator: Heze Han, MD Beijing Tiantan Hospital
Principal Investigator: Wenxiong Song, MD Beijing Tiantan Hospital
Principal Investigator: Jionghao Xue, MD Beijing Tiantan Hospital
Principal Investigator: Minghao Liu, MD Beijing Tiantan Hospital
More Information
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Responsible Party: Xiaolin Chen, MD, Director, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT05961748    
Other Study ID Numbers: KY2022-221-02
First Posted: July 27, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Cerebral Hemorrhage
Cerebral Infarction
Intracranial Aneurysm
Moyamoya Disease
Atrial Fibrillation
Myocardial Ischemia
Coronary Artery Disease
Arteriovenous Malformations
Aortic Diseases
Constriction, Pathologic
Hemorrhage
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
 Pathologic Processes
Infarction
Ischemia
Necrosis
Pathological Conditions, Anatomical
Aneurysm
Vascular Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Congenital Abnormalities
Coronary Disease
Arteriosclerosis