BHC-C: Registry of Multicenter Brain-Heart Comorbidity in China

Sponsor
Beijing Tiantan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05961748
Collaborator
(none)
100,000
14
252
7142.9
28.3

Study Details

Study Description

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).

Study Design

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

Outcome Measures

Primary Outcome Measures

  1. Rate of Participants with Composite of All-Cause Mortality and Cardiovascular Outcomes [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 [At discharge/30 days]

    The occurrence of death

  3. Rate of Participants with Composite of Cardiovascular Outcomes [At discharge/30 days]

    The occurrence of coronary artery disease event, stroke (ischemic or hemorrhagic), heart failure, or atrial fibrillation etc.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 Beijing Tiantan Hospital, Capital Medical University Beijing Beijing China 100070
2 Beijing Anzhen Hospital, Capital Medical University Beijing Beijing China
3 Beijing Chaoyang Hospital, Capital Medical University Beijing Beijing China
4 Chinese People's Liberation Army (PLA) General Hospital Beijing Beijing China
5 Peking University First Hospital Beijing Beijing China
6 Xuanwu Hospital, Capital Medical University Beijing Beijing China
7 The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian China
8 The First Affiliated Hospital of Xiamen University Xiamen Fujian China
9 Shenzhen Qianhai Shekou Free Trade Zone Hospital Shenzhen Guangdong China
10 The First Affiliated Hospital of Harbin Medical University Harbin Heilongjiang China
11 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China
12 Huashan Hospital of Fudan University Shanghai Shanghai China
13 Shanxi Provincial People's Hospital Shanxi Shanxi China
14 The Second Affiliated Hospital of Kunming Medical University Kunming Yunnan China

Sponsors and Collaborators

  • Beijing Tiantan Hospital

Investigators

  • 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: Shaui 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiaolin Chen, MD, Director, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier:
NCT05961748
Other Study ID Numbers:
  • KY2022-221-02
First Posted:
Jul 27, 2023
Last Update Posted:
Jul 27, 2023
Last Verified:
Jul 1, 2023

Study Results

No Results Posted as of Jul 27, 2023