Cohort Study for Severe Ischaemic Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Features, Management and Outcomes of Severe Ischaemic Stroke in Tertiary Hospitals in China: a Multi-centre Prospective Observational Study

Conditions
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Severe Ischaemic Stroke, Malignant Ischaemic Stroke

Intervention / Treatment
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* Other: routine medical care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years or over Symptoms and signs of clinically definite acute stroke Time of stroke onset is known and within 30 days of admission CT or MRI brain scanning has reliably excluded both intracranial haemorrhage and structural brain lesions which can mimic stroke (e.g. brain tumour) Exclusion Criteria: Likely to be unavailable for follow-up, e.g. no fixed home address Refuse to give consent to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Severe ischaemic stroke<br>patients with severe stroke on admission | Other: routine medical care<br>* 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<br>|
| Malignant ischaemic stroke<br>patients without severe stroke on admission but developing it in hospital | Other: routine medical care<br>* 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<br>|
| Mild to moderate ischaemic stroke<br>patients without severe stroke from onset to discharge | Other: routine medical care<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome at 3 months after stroke onset | Modified Rankin scale score of patients at 3 months after the onset of ischaemic stroke. | 3 months after stroke onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with initially severe ischaemic stroke | Initially severe ischaemic stroke is defined as a) severe neurological deficits, assessed by the National Institute of Health Stroke Scale (NIHSS) scored 15 or over, b) loss of consciousness, assessed by the Glasgow Coma Scale (GCS) scored 8 or less, or item 1a of NIHSS scored 1 or over, or c) intubation, mechanical ventilation, or admitted to intensive care unit on admission. | 24 hours after admission | 
| Proportion of patients experiencing clinical worsening following acute ischaemic stroke | Clinical worsening is defined as a) neurological deterioration with an increase of NIHSS score of 4 or more as compared to baseline NIHSS, b) a decline of consciousness, which leads to a GCS score of 8 or less, or item 1a of NIHSS scored 1 or over, c) need for invasive interventions such as hemicraniectomy, or d) death in hospital. | 30 days after admission | 
| Proportion of patients with malignant brain oedema following acute ischaemic stroke | Malignant brain oedema is defined as symptoms or signs of clinical worsening associated with imaging evidence of space-occupying brain oedema. | 30 days after admission | 
| Clinical course of stroke severity in patients with initially severe stroke | Dynamically record scores of National Institute of Health Stroke Scale (NIHSS) from day 0, day 3, day 7 to day 30 after admission. | 30 days after admission | 
| Changes in consicousness level of patients with initially severe stroke from day 0, day 3, day 7 to day 30 after admission. | Dynamically record scores of Glasgow Coma Scale (GCS) | 30 days after admission | 
| Functional outcome at 1 year after stroke onset | Modified Rankin scale score of patients at 1 year after the onset of ischaemic stroke. | 1 year after stroke onset | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischaemic stroke, severe, malignant, courses, risk factors, clinical course, management, prognosis