Cohort Study for Severe Ischaemic Stroke "SIS"

Recruiting

Phase N/A Results N/A

Trial 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).

Detailed Description

Nine tertiary hospitals in Western China are participating in the study. In each participating hospital, stroke patients admitted to the Department of Neurology will be screened by their responsible doctors for eligibility. For patients who are potentially eligible, the doctor will introduce this study in detail with written information to the patient or their legal proxies. After participants (or their proxies) sign the consent form, investigators will collect their baseline data within 24 hours after admission (visit 1). Subsequent visits will be conducted on day 3 of admission or if the patient experiences neurological deterioration between visit 1 and day 3 (visit 2), on day 7 of admission or if neurological deterioration occurs between visit 2 and day 7 (visit 3), and on the day before discharge or on day 30 of admission, whichever is earlier (visit 4). At visit 1 investigators will record demographics, medical history, characteristics of current stroke, and results of the blood tests, brain imaging and other examinations, if applicable. At visit 4, investigators will record interventions and rehabilitation used during hospitalisation. At day 90 and 1 year of stroke onset, a trained investigator (neurologist) blind to all medical information will contact the participant to deliver a structured telephone interview and collect their functional outcomes.
Objectives of this study are: a) to explore causes of clinical worsening in acute ischaemic stroke, and for each type of clinical worsening to dynamically evaluate its clinical course and explore its risk factors; b) to explore the application of conventional stroke therapies in patients with severe ischaemic stroke in China; c) to investigate factors precipitating and predisposing malignant brain oedema following acute ischaemic stroke; and d) to better select patients with malignant brain oedema for individualised treatment strategies.

Conditions

Interventions

  • Routine medical care Other
    Intervention Desc: This is an observational study for clinical course and outcomes of severe ischaemic stroke; therefore, interventions are prescribed by responsible doctors based on patients' clinical conditions, which is not interfered by current study
    ARM 1: Kind: Experimental
    Label: Severe ischaemic stroke
    Description: patients with severe stroke on admission
    ARM 2: Kind: Experimental
    Label: Malignant ischaemic stroke
    Description: patients without severe stroke on admission but developing it in hospital
    ARM 3: Kind: Experimental
    Label: Mild to moderate ischaemic stroke
    Description: patients without severe stroke from onset to discharge

Trial Population

Patients with acute ischaemic stroke admitted to the Department of Neurology of nine participating hospitals will be included if they meet all inclusion criteria and do not have any exclusion criteria.

Outcomes

Type Measure Time Frame Safety Issue
Primary Functional outcome at 3 months after severe/malignant ischaemic stroke 3 months after stroke onset
Primary Predictors for good functional outcome at 3 months after severe/malignant ischaemic stroke 3 months after stroke onset
Secondary Factors associated with the development of initially severe stroke 3 months after stroke onset
Secondary Factors associated with the development of malignant stroke 3 months after stroke onset
Secondary Clinical course of severe/malignant stroke 3 months after stroke onset
Secondary Functional outcome at 1 year after severe/malignant ischaemic stroke 1 year after stroke onset
Secondary Predictors for good functional outcome at 1 year after severe/malignant ischaemic stroke 1 year after stroke onset
Primary Functional outcome at 3 months after stroke onset 3 months after stroke onset
Secondary Proportion of patients with initially severe ischaemic stroke 24 hours after admission
Secondary Proportion of patients experiencing clinical worsening following acute ischaemic stroke 30 days after admission
Secondary Proportion of patients with malignant brain oedema following acute ischaemic stroke 30 days after admission
Secondary Clinical course of stroke severity in patients with initially severe stroke 30 days after admission
Secondary Changes in consicousness level of patients with initially severe stroke from day 0, day 3, day 7 to day 30 after admission. 30 days after admission
Secondary Functional outcome at 1 year after stroke onset 1 year after stroke onset

Biospecimen Retention:Samples With DNA - We will collect blood samples from patients with their written consent

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