NCT04775836

Brief Summary

In this protocol, the investigators present methods and preliminary results from the PLATFORM-CVD Study, an EHR-based multicenter cohort. This study will focus on assessing the distribution of major cerebrovascular diseases, determining the risk factors associated with disease incidence and worse in-hospital outcomes, as well as describing the quality of care. Data from this cohort will be used to develop suitable prediction models for cerebrovascular diseases using real-world data and to understand how outcomes for cerebrovascular diseases would change with quality improvement interventions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

February 5, 2021

Last Update Submit

February 26, 2021

Conditions

Keywords

Healthcare QualityElectronic Health RecordsCerebrovascular Diseases

Outcome Measures

Primary Outcomes (3)

  • In-hospital mortality

    Patients who died during hospitalization due to cerebrovascular diseases

    From date of hospitalization until the date of discharge, assessed up to 90 days

  • Length of stay at hospital

    The total days for a patients with cerebrovascular diseases at hospitalization

    From date of hospitalization until the date of discharge, assessed up to 90 days

  • Costs

    The total costs for a patients with cerebrovascular diseases at hospitalization

    From date of hospitalization until the date of discharge, assessed up to 90 days

Secondary Outcomes (21)

  • Rate of antiplatelet medication use

    From date of hospitalization until the date of discharge, assessed up to 90 days

  • Rate of dual antiplatelet medication use for non-disabling IS and TIA events

    From date of hospitalization until the date of discharge, assessed up to 90 days

  • Rate of DVT prophylaxis ≤ 48 hours

    48 hours within hospitalization

  • Cerebrovascular assessment ≤ seven days

    7 days within hospitalization

  • Statin therapy for LDL ≥100 mg/dL during hospitalization

    From date of hospitalization until the date of discharge, assessed up to 90 days

  • +16 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Twenty-five hospitals were enrolled in the PLATFORM-CVD Study between January 1st, 2017 and May 20th, 2020. Hospitals were included if they: 1) had neurological wards; 2) were secondary or tertiary hospitals; 3) could admit at least 20 cerebrovascular disease patients every month.

You may qualify if:

  • Patients were included in the registry if they were hospitalized with a primary diagnose of:
  • cerebral infarction (I63)
  • nontraumatic intracerebral hemorrhage (I61)
  • nontraumatic subarachnoid hemorrhage (I60)
  • transient cerebral ischemic attack and related syndromes (G45)
  • intracranial and intraspinal phlebitis and thrombophlebitis (G08)
  • vascular dementia (F01)
  • other aneurysms (I72)

You may not qualify if:

  • Patients diagnosed with other diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

StrokeCerebrovascular DisordersCerebral InfarctionCerebral HemorrhageIschemic Attack, TransientSubarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain InfarctionBrain IschemiaInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisIntracranial HemorrhagesHemorrhage

Study Officials

  • Zi-Xiao Li, PhD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meng Wang, PhD

CONTACT

Xin Yang, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 5, 2021

First Posted

March 1, 2021

Study Start

January 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

March 1, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

We will share the data dictionary of the study. The data could be applied by the PI's email. Applicant should make an SAP first. The PI will check the SAP and appoint a statistician for the analysis.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The data will be available when the data collection finished.

Locations