NCT05961748

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
81mo left

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Jan 2012Dec 2032

Study Start

First participant enrolled

January 1, 2012

Completed
11.5 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

21 years

First QC Date

July 7, 2023

Last Update Submit

September 16, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

Multi-disciplinary assessment

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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).

You may not qualify if:

  • ·refuse to participate in the registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Chinese People's Liberation Army (PLA) General Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

NOT YET RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

NOT YET RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

NOT YET RECRUITING

Shenzhen Qianhai Shekou Free Trade Zone Hospital

Shenzhen, Guangdong, China

NOT YET RECRUITING

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

NOT YET RECRUITING

Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Shanxi Provincial People's Hospital

Shanxi, Shanxi, China

NOT YET RECRUITING

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

NOT YET RECRUITING

MeSH Terms

Conditions

Myocardial IschemiaHeart ArrestAtrial FibrillationHeart FailureAortic DiseasesSubarachnoid HemorrhageCerebral HemorrhageCerebral InfarctionBites and StingsIntracranial AneurysmMoyamoya DiseaseIntracranial Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and SymptomsIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHemorrhageBrain InfarctionBrain IschemiaStrokeInfarctionIschemiaNecrosisPoisoningChemically-Induced DisordersWounds and InjuriesIntracranial Arterial DiseasesAneurysmCarotid Artery DiseasesCerebral Arterial DiseasesArterial Occlusive DiseasesCentral Nervous System Vascular MalformationsNervous System MalformationsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Shuo Wang, MD

    Beijing Tiantan Hospital

    STUDY CHAIR
  • Yong Cao, MD

    Beijing Tiantan Hospital

    STUDY DIRECTOR
  • Dong Xu, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR
  • Zening Jin, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR
  • Hao Wang, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR
  • Shuai 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

    PRINCIPAL INVESTIGATOR
  • Wenxiong Song, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR
  • Jionghao Xue, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR
  • Minghao Liu, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaolin Chen, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 7, 2023

First Posted

July 27, 2023

Study Start

January 1, 2012

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

December 31, 2032

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations