Computer-based Online Database of Acute Stroke Patients for Stroke Management Quality Evaluation
November 21, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
In the past three decades, the burden of stroke has increased in China and has gradually become the leading cause of death.
The data acquisition and medical quality management still need to be improved in China.
The purpose of this study was to establish online database of acute stroke patients for stroke management quality evaluation in China.
Study Overview
Detailed Description
This study is a prospective multi-center registration study.
The data of acute ischemic stroke patients who underwent reperfusion therapy were registered on emergency platform.
The data of stroke patients who were hospitalized were registered on stroke meidical quality control platform.
The information including demographics, risk factors (history of hypertension, diabetes, stroke/TIA or atrial fibrillation, etc), prior antiplatelet usage, onset to door time (ODT), baseline National Institutes of Health Stroke Scale (NIHSS) score, baseline infarct core volume, laboratory data, ect were recorded.
Clinical outcome at 3 months and 1 year was assessed.
Study Type
Observational
Enrollment (Anticipated)
200000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- Recruiting
- Min Lou
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All acute stroke patients who were admitted to hospital.
Description
Inclusion Criteria:
Acute stroke patients
Exclusion Criteria:
No
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Independence (mRS 0-2) at 1 year
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
All-cause mortality at 1 year
Time Frame: 1 year
|
1 year
|
|
Brain hemorrhage at 24-72 hours after hospitalization
Time Frame: 72 hours
|
72 hours
|
|
The incidence of recurrent stroke or other vascular events at 1 year
Time Frame: 1 year
|
1 year
|
|
Independence (mRS 0-2) at 5 year
Time Frame: 5 year
|
5 year
|
|
The incidence of recurrent stroke or other vascular events at 5 year
Time Frame: 5 year
|
5 year
|
|
All-cause mortality at 5 year
Time Frame: 5 year
|
5 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2016
Primary Completion (ANTICIPATED)
July 1, 2027
Study Completion (ANTICIPATED)
July 1, 2028
Study Registration Dates
First Submitted
July 19, 2020
First Submitted That Met QC Criteria
July 24, 2020
First Posted (ACTUAL)
July 27, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 23, 2022
Last Update Submitted That Met QC Criteria
November 21, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASE II
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.