Registry of Multicenter Brain-Heart Comorbidity in China | NCT05961748

Studies
Registry of Multicenter Brain-Heart Comorbidity in China

NCT05961748

Sponsor

Beijing Tiantan Hospital

Status

Recruiting

Last Update Posted

Sep 21, 2023Actual

Enrollment

100,000Estimated

Phase

Not provided

Conditions

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

Interventions

Multi-disciplinary assessment

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2012Actual

Primary Completion Date

Dec 31, 2032Estimated

Completion Date

Dec 31, 2032Estimated

First Submitted Date

Jul 7, 2023

First Submission Date that Met QC Criteria

Jul 23, 2023

First Posted Date

Jul 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2023

Last Update Posted Date

Sep 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Conditions Module

Conditions

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

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
Multi-disciplinary assessment	Other	Multi-disciplinary assessment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaolin Chen, MD	Contact	13810624845		cxl_bjtth@163.com
Fa Lin, MD	Contact	13681107240		13681107240@163.com

Overall Officials

Name	Affiliation	Role
Shuo Wang, MD	Beijing Tiantan Hospital	Study Chair
Yong Cao, MD	Beijing Tiantan Hospital	Study Director
Dong Xu, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Tiantan Hospital, Capital Medical University	Recruiting	Beijing	Beijing Municipality	100070	China

ID	Term
D017202	Myocardial Ischemia
D006323	Heart Arrest
D001281	Atrial Fibrillation
D006333	Heart Failure
D001018	Aortic Diseases
D013345	Subarachnoid Hemorrhage
D002543	Cerebral Hemorrhage
D002544	Cerebral Infarction
D001733	Bites and Stings
D002532	Intracranial Aneurysm
D009072	Moyamoya Disease
D002538	Intracranial Arteriovenous Malformations

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D001145	Arrhythmias, Cardiac
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D006470	Hemorrhage
D020520	Brain Infarction
D002545	Brain Ischemia
D020521	Stroke
D007238	Infarction
D007511	Ischemia
D009336	Necrosis
D011041	Poisoning
D064419	Chemically-Induced Disorders
D014947	Wounds and Injuries
D020765	Intracranial Arterial Diseases
D000783	Aneurysm
D002340	Carotid Artery Diseases
D002539	Cerebral Arterial Diseases
D001157	Arterial Occlusive Diseases
D020785	Central Nervous System Vascular Malformations
D009421	Nervous System Malformations
D001165	Arteriovenous Malformations
D054079	Vascular Malformations
D018376	Cardiovascular Abnormalities
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities