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

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).

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Atrial Fibrillation; Ischemic Heart Disease; Cerebral Infarction; Cardiac Arrest; Moyamoya Disease; Subarachnoid Hemorrhage; Aortic Diseases; Cerebral Aneurysm; Intracerebral Hemorrhage; Occlusion and Stenosis of Precerebral Arteries; Occlusion and Stenosis of Cerebellar Arteries; Arteriovenous Malformation of Cerebral Vessels
• Intervention / Treatment: Other: Multi-disciplinary assessment

• Study Type: Observational
• Enrollment (Estimated): 100000

Contacts and Locations

• Study Contact: Name: Xiaolin Chen, MD; Phone Number: 13810624845; Email: cxl_bjtth@163.com
• Study Contact Backup: Name: Fa Lin, MD; Phone Number: 13681107240; Email: 13681107240@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Recruiting
      • Beijing Tiantan Hospital, Capital Medical University
      • Contact: Fa Lin, MD; Phone Number: 13681107240; Email: 13681107240@163.com
    • Beijing, Beijing, China
      • Not yet recruiting
      • Peking University First Hospital
      • Contact: Wei MA, MD
      • Contact: Xinggang Wang, MD
    • Beijing, Beijing, China
      • Not yet recruiting
      • Beijing Anzhen Hospital, Capital Medical University
      • Contact: Ming Gong, MD
      • Contact: Hai Gao, MD
    • Beijing, Beijing, China
      • Not yet recruiting
      • Beijing Chaoyang Hospital, Capital Medical University
      • Contact: Xiaojuan Guo, MD
    • Beijing, Beijing, China
      • Not yet recruiting
      • Chinese People's Liberation Army (PLA) General Hospital
      • Contact: Hang Zhu, MD
    • Beijing, Beijing, China
      • Not yet recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Yingqi Xing, MD
  • Fujian
    • Fuzhou, Fujian, China
      • Not yet recruiting
      • The First Affiliated Hospital of Fujian Medical University
      • Contact: Dezhi Kang, MD
    • Xiamen, Fujian, China
      • Not yet recruiting
      • The First Affiliated Hospital of Xiamen University
      • Contact: Sifang Chen, MD
  • Guangdong
    • Shenzhen, Guangdong, China
      • Not yet recruiting
      • Shenzhen Qianhai Shekou Free Trade Zone Hospital
      • Contact: Zhiwei Wang, MD
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Not yet recruiting
      • The First Affiliated Hospital of Harbin Medical University
      • Contact: Huaizhang Shi, MD
  • Henan
    • Zhengzhou, Henan, China
      • Not yet recruiting
      • The First Affiliated Hospital of Zhengzhou University
      • Contact: Dongming Yan, MD
      • Contact: Guosheng Zhou, MD
  • Shanghai
    • Shanghai, Shanghai, China
      • Not yet recruiting
      • Huashan Hospital of Fudan University
      • Contact: Bin Xu, MD
      • Contact: Feng Xu, MD
  • Shanxi
    • Shanxi, Shanxi, China
      • Not yet recruiting
      • Shanxi Provincial People's Hospital
      • Contact: Shaohua Ren, MD
  • Yunnan
    • Kunming, Yunnan, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Kunming Medical University
      • Contact: Jun Pu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
All-Cause Mortality	The occurrence of death	At discharge/30 days
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

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Yu Chen, MD, Beijing Tiantan Hospital; Principal Investigator: Runting Li, MD, Beijing Tiantan Hospital; Principal Investigator: Heze Han, MD, Beijing Tiantan Hospital; 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: Qingyuan Liu, MD, Beijing Tiantan Hospital; Principal Investigator: Shuai Kang, 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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 23, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 16, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Arrhythmias, Cardiac; Brain Ischemia; Coronary Disease; Carotid Artery Diseases; Infarction; Stroke; Brain Infarction; Cardiovascular Abnormalities; Vascular Malformations; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Intracranial Hemorrhages; Aneurysm; Coronary Artery Disease; Myocardial Ischemia; Atrial Fibrillation; Hemorrhage; Cerebral Infarction; Constriction, Pathologic; Arteriovenous Malformations; Moyamoya Disease; Subarachnoid Hemorrhage; Cerebral Hemorrhage; Intracranial Aneurysm; Aortic Diseases
• Other Study ID Numbers: KY2022-221-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No