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

September 16, 2023 updated by: Xiaolin Chen, MD, Beijing Tiantan Hospital

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

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital, Capital Medical University
        • Contact:
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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