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Computer-based Online Database of Acute Stroke Patients for Stroke Management Quality Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04487340
Recruitment Status : Recruiting
First Posted : July 27, 2020
Last Update Posted : November 23, 2022
Sponsor:
Collaborators:
Shaoxing People's Hospital
Affiliated Hospital of Jiaxing University
Huizhou Municipal Central Hospital
The Second Affiliated Hospital of Jiaxing University
Jinhua Center Hospital
Taizhou Hospital
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment
Stroke, Acute Behavioral: Education

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Computer-based Online Database of Acute Stroke Patients for Stroke Management Quality Evaluation
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : July 1, 2027
Estimated Study Completion Date : July 1, 2028

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Behavioral: Education
    Provide each center with relevant education of guidelines, and help the clinicians to improve medical quality.

Outcome Measures
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Primary Outcome Measures :
  1. Independence (mRS 0-2) at 1 year [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. All-cause mortality at 1 year [ Time Frame: 1 year ]
  2. Brain hemorrhage at 24-72 hours after hospitalization [ Time Frame: 72 hours ]
  3. The incidence of recurrent stroke or other vascular events at 1 year [ Time Frame: 1 year ]
  4. Independence (mRS 0-2) at 5 year [ Time Frame: 5 year ]
  5. The incidence of recurrent stroke or other vascular events at 5 year [ Time Frame: 5 year ]
  6. All-cause mortality at 5 year [ Time Frame: 5 year ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All acute stroke patients who were admitted to hospital.
Criteria

Inclusion Criteria:

Acute stroke patients

Exclusion Criteria:

No

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04487340


Contacts
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Contact: Min Lou, PhD 13958007213 loumingxc@vip.sina.com

Locations
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China, Zhejiang
Min Lou Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Zexin Chen    13757118366    HREC2013@126.com   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Shaoxing People's Hospital
Affiliated Hospital of Jiaxing University
Huizhou Municipal Central Hospital
The Second Affiliated Hospital of Jiaxing University
Jinhua Center Hospital
Taizhou Hospital
Investigators
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Study Director: Min Lou, PhD Second Affiliated Hospital, School of Medicine, Zhejiang University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04487340    
Other Study ID Numbers: CASE II
First Posted: July 27, 2020    Key Record Dates
Last Update Posted: November 23, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
thrombolysis
thrombectomy
hospitalization
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases