ClinicalTrials.gg
RecruitingNCT05961748BHC-CUpdated Sep 21, 2023

Registry of Multicenter Brain-Heart Comorbidity in China

An observational study in Ischemic Heart Disease, Cardiac Arrest and Atrial Fibrillation, sponsored by Beijing Tiantan Hospital. Recruiting at 14 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Beijing Tiantan Hospital · Observational

From the registry’s dates

  • Started Jan 2012; still recruiting 14 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100,000
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • 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
03

In context

Myocardial Ischemia

1,123 studies on the registry are indexed under Myocardial Ischemia; 177 are open to participants now.

This study's planned enrollment of 100,000 is above the median of 318 across 398 observational studies indexed under Myocardial Ischemia.

Browse Myocardial Ischemia studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

·refuse to participate in the registry

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100,000 participants (estimated)
Patient registry
No

Interventions

  • OtherMulti-disciplinary assessment

    Multi-disciplinary assessment

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At discharge/30 days

  2. All-Cause Mortality

    The occurrence of death

    Time frame: At discharge/30 days

  3. 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.

    Time frame: At discharge/30 days

07

Study locations

1 of 14 sites recruiting
  • Beijing Tiantan Hospital, Capital Medical University
    Beijing, Beijing 100070, China
    Recruiting
  • Beijing Anzhen Hospital, Capital Medical University
    Beijing, Beijing, China
    Not yet recruiting
    • Ming Gong, MD · Contact
    • Hai Gao, MD · Contact
  • Beijing Chaoyang Hospital, Capital Medical University
    Beijing, Beijing, China
    Not yet recruiting
    • Xiaojuan Guo, MD · Contact
  • Chinese People's Liberation Army (PLA) General Hospital
    Beijing, Beijing, China
    Not yet recruiting
    • Hang Zhu, MD · Contact
  • Peking University First Hospital
    Beijing, Beijing, China
    Not yet recruiting
    • Wei Ma, MD · Contact
    • Xinggang Wang, MD · Contact
  • Xuanwu Hospital, Capital Medical University
    Beijing, Beijing, China
    Not yet recruiting
    • Yingqi Xing, MD · Contact
  • The First Affiliated Hospital of Fujian Medical University
    Fuzhou, Fujian, China
    Not yet recruiting
    • Dezhi Kang, MD · Contact
  • The First Affiliated Hospital of Xiamen University
    Xiamen, Fujian, China
    Not yet recruiting
    • Sifang Chen, MD · Contact
  • Shenzhen Qianhai Shekou Free Trade Zone Hospital
    Shenzhen, Guangdong, China
    Not yet recruiting
    • Zhiwei Wang, MD · Contact
  • The First Affiliated Hospital of Harbin Medical University
    Harbin, Heilongjiang, China
    Not yet recruiting
    • Huaizhang Shi, MD · Contact
  • The First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan, China
    Not yet recruiting
    • Dongming Yan, MD · Contact
    • Guosheng Zhou, MD · Contact
  • Huashan Hospital of Fudan University
    Shanghai, Shanghai, China
    Not yet recruiting
    • Bin Xu, MD · Contact
    • Feng Xu, MD · Contact
  • Shanxi Provincial People's Hospital
    Shanxi, Shanxi, China
    Not yet recruiting
    • Shaohua Ren, MD · Contact
  • The Second Affiliated Hospital of Kunming Medical University
    Kunming, Yunnan, China
    Not yet recruiting
    • Jun Pu, MD · Contact
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2012 (actual). Primary completion is estimated for Dec 2032, 251 months after the start.

Of 165 non-industry observational studies under Myocardial Ischemia, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 127. This study's planned 251 months is above that.

Counting every sponsor, half of 204 studies reached it within 40 months; a quarter within 21 and three quarters within 90.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 7, 2023
First posted
Jul 27, 2023
StartActual
Jan 1, 2012
Primary completionEst.
Dec 31, 2032
CompletionEst.
Dec 31, 2032
Last update
Sep 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05961748
Responsible party
Xiaolin Chen, MD (Director, Beijing Tiantan Hospital) — Principal investigator
First posted
Jul 27, 2023
Start date
Jan 1, 2012
Primary completion
Dec 31, 2032 (estimated)
Completion
Dec 31, 2032 (estimated)
Last update
Sep 21, 2023

Study contacts

Xiaolin Chen, MD
Contact
cxl_bjtth@163.com
13810624845
Fa Lin, MD
Contact
13681107240@163.com
13681107240
Shuo Wang, MD
study chair · Beijing Tiantan Hospital
Yong Cao, MD
study director · Beijing Tiantan Hospital
Dong Xu, MD
principal investigator · Beijing Tiantan Hospital
Zening Jin, MD
principal investigator · Beijing Tiantan Hospital
Hao Wang, MD
principal investigator · Beijing Tiantan Hospital
Shuai Kang, MD
principal investigator · Beijing Tiantan Hospital
Yu Chen, MD
principal investigator · Beijing Tiantan Hospital
Qingyuan Liu, MD
principal investigator · Beijing Tiantan Hospital
Runting Li, MD
principal investigator · Beijing Tiantan Hospital
Heze Han, MD
principal investigator · Beijing Tiantan Hospital
Wenxiong Song, MD
principal investigator · Beijing Tiantan Hospital
Jionghao Xue, MD
principal investigator · Beijing Tiantan Hospital
Minghao Liu, MD
principal investigator · Beijing Tiantan Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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