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

Recruiting

• Conditions: Stroke, Acute

• Registration Number: NCT04487340
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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 Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2020-07-19
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-27
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-21
• Last Update Posted: 2022-11-23
• Primary Completion: 2027-07-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200000

Inclusion Criteria

Acute stroke patients

Exclusion Criteria

No

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Independence (mRS 0-2) at 1 year	1 year

Secondary Outcome Measures

Name	Time	Method
The incidence of recurrent stroke or other vascular events at 5 year	5 year
The incidence of recurrent stroke or other vascular events at 1 year	1 year
Independence (mRS 0-2) at 5 year	5 year
All-cause mortality at 5 year	5 year
Brain hemorrhage at 24-72 hours after hospitalization	72 hours
All-cause mortality at 1 year	1 year

Trial Locations

Locations (1)

Min Lou; 🇨🇳 Hangzhou, Zhejiang, China