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NCT03222024: SIS

Cohort Study for Severe Ischaemic Stroke

Completed Last updated 28 October 2020
What this trial tests

trial testing routine medical care in Severe Ischaemic Stroke in 2,500 participants. Completed in 31 August 2020.

Timeline
12 September 2017
Primary endpoint
31 December 2019
31 August 2020

Quick facts

Lead sponsorWest China Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment2,500
Start date12 September 2017
Primary completion31 December 2019
Estimated completion31 August 2020
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

West China Hospital

Who can join

18 and older, any sex, with Severe Ischaemic Stroke or Malignant Ischaemic Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multi-centre, prospective cohort study. The aim of this study is to investigate causes, risk factors, clinical course, management and outcomes of severe ischaemic stroke in a real-world setting in tertiary hospitals in China. Patients with acute ischaemic stroke from nine tertiary hospitals in western China will be recruited. Participants will be visited within 24 hours after admission, on day 3, day 7 and at discharge, to collect their clinical data, blood biomarkers, and brain imaging. A structured telephone interview will be conducted for each participant at 3 months and 1 year after stroke onset, respectively, to collect their functional outcomes. In-hospital outcomes include haemorrhagic transformation, brain oedema and death, 3-month and 1-year outcomes include survival status (death or survival) and functional outcome (scores of modified Rankin scale, mRS).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Predicting the emergence of malignant brain oedema in acute ischaemic stroke: a prospective multicentre study with development and validation of predictive modelling.
    Wu S, Wang Y, Yuan R, Guo F, et al · · 2023 · cited 26× · PMID 37152361 · DOI 10.1016/j.eclinm.2023.101977
  2. Association between serum NLRP3 and malignant brain edema in patients with acute ischemic stroke.
    Wang Y, Huang H, He W, Zhang S, et al · · 2021 · cited 24× · PMID 34493232 · DOI 10.1186/s12883-021-02369-4
  3. Clinical features, management and outcomes of severe ischaemic stroke in tertiary hospitals in China: protocol for a prospective multicentre registry-based observational study.
    Wu S, Yuan R, Xiong Y, Zhang S, et al · · 2018 · cited 10× · PMID 30373783 · DOI 10.1136/bmjopen-2018-024900
  4. Precision management of brain oedema after acute ischaemic stroke.
    Wu S, Anderson CS. · · 2022 · cited 8× · PMID 35990896 · DOI 10.1093/pcmedi/pbac019
  5. Clinical course, causes of worsening, and outcomes of severe ischemic stroke: A prospective multicenter cohort study.
    Wu S, Wang Y, Yuan R, Liu M, et al · · 2025 · cited 2× · PMID 40090964 · DOI 10.1097/cm9.0000000000003556
  6. Association of fluid balance with 3-month outcomes in severe acute ischaemic stroke.
    Liu M, Wang Y, Hua X, Huang L, et al · · 2026 · PMID 40738754 · DOI 10.1136/svn-2024-004001

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