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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

Tracking Information
First Submitted Date July 19, 2020
First Posted Date July 27, 2020
Last Update Posted Date November 23, 2022
Actual Study Start Date January 1, 2016
Estimated Primary Completion Date July 1, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 24, 2020)		 Independence (mRS 0-2) at 1 year [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 24, 2020)
  • All-cause mortality at 1 year [ Time Frame: 1 year ]
  • Brain hemorrhage at 24-72 hours after hospitalization [ Time Frame: 72 hours ]
  • The incidence of recurrent stroke or other vascular events at 1 year [ Time Frame: 1 year ]
  • Independence (mRS 0-2) at 5 year [ Time Frame: 5 year ]
  • The incidence of recurrent stroke or other vascular events at 5 year [ Time Frame: 5 year ]
  • All-cause mortality at 5 year [ Time Frame: 5 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Computer-based Online Database of Acute Stroke Patients for Stroke Management Quality Evaluation
Official Title Computer-based Online Database of Acute Stroke Patients for Stroke Management Quality Evaluation
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.
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 [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All acute stroke patients who were admitted to hospital.
Condition Stroke, Acute
Intervention Behavioral: Education
Provide each center with relevant education of guidelines, and help the clinicians to improve medical quality.
Study Groups/Cohorts Not Provided
Publications * Wang J, Zhang J, Gong X, Zhang W, Zhou Y, Lou M. Prediction of large vessel occlusion for ischaemic stroke by using the machine learning model random forests. Stroke Vasc Neurol. 2022 Apr;7(2):94-100. doi: 10.1136/svn-2021-001096. Epub 2021 Oct 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 24, 2020)		 200000
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 1, 2028
Estimated Primary Completion Date July 1, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Acute stroke patients

Exclusion Criteria:

No
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Min Lou, PhD 13958007213 loumingxc@vip.sina.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04487340
Other Study ID Numbers CASE II
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Second Affiliated Hospital, School of Medicine, Zhejiang University
Original Responsible Party Same as current
Current Study Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Original Study Sponsor Same as current
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
Investigators
Study Director: Min Lou, PhD Second Affiliated Hospital, School of Medicine, Zhejiang University
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date November 2022