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Recruiting NCT04487340

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

— Observational Stroke, Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Education.
Who it may be relevant to
Registry conditions: Stroke, Acute. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Independence (mRS 0-2) at 1 year [Time frame: 1 year]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

Inclusion criteria

Acute stroke patients

Exclusion criteria

No

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

China · 1 center
  • Min Lou — Hangzhou

Publications

  • Zhou H, Zhong W, Zhang T, Xu C, Zhong G, Xie G, Zhang B, Chen H, Wang E, Xu D, Cheng C, Yang J, Lou M, Yan S; CASE-II Study Group. Comparing Outcomes of Thrombectomy Versus Intravenous Thrombolysis Based on Middle Cerebral Artery M2 Occlusion Features. Stroke. 2024 Jun;55(6):1592-1600. doi: 10.1161/STROKEAHA.123.044986. Epub 2024 May 24. PMID 38787930
  • Xue R, Zhong W, Zhou Y, He Y, Yan S, Chen Z, Wang J, Gong X, Lou M. Endovascular Treatment for Minor Acute Ischemic Strokes With Large Vessel Occlusion. J Am Heart Assoc. 2022 Dec 20;11(24):e027326. doi: 10.1161/JAHA.122.027326. Epub 2022 Dec 19. PMID 36533622
  • 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. PMID 34702747

Identifiers

NCT: NCT04487340 · CASE II

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗