Cohort Study for Severe Ischaemic Stroke (SIS)

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

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).

Study Overview

• Status: Completed
• Conditions: Severe Ischaemic Stroke; Malignant Ischaemic Stroke
• Intervention / Treatment: Other: routine medical care

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.

• Study Type: Observational
• Enrollment (Actual): 2500

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Severe ischaemic stroke; patients with severe stroke on admission	Other: routine medical care; 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
Malignant ischaemic stroke; patients without severe stroke on admission but developing it in hospital	Other: routine medical care; 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
Mild to moderate ischaemic stroke; patients without severe stroke from onset to discharge	Other: routine medical care; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: West China Hospital
• Collaborators: National Natural Science Foundation of China; Chengdu University of Traditional Chinese Medicine; Sichuan Academy of Medical Sciences; The Affiliated Hospital Of Southwest Medical University; Mianyang Central Hospital; Affiliated Hospital of North Sichuan Medical College; People's Hospital of Deyang City; The First People's Hospital of Ziyang; Jiangyou People's Hospital; Science & Technology Department of Sichuan Province
• Investigators: Study Chair: Ming Liu, MD, West China Hospital; Study Director: Shihong Zhang, MD, West China Hospital; Principal Investigator: Simiao Wu, MD, PhD, West China Hospital

Publications and helpful links

General Publications

• Wu S, Yuan R, Xiong Y, Zhang S, Wu B, Liu M. Clinical features, management and outcomes of severe ischaemic stroke in tertiary hospitals in China: protocol for a prospective multicentre registry-based observational study. BMJ Open. 2018 Oct 28;8(10):e024900. doi: 10.1136/bmjopen-2018-024900.
• Wu S, Yuan R, Wang Y, Wei C, Zhang S, Yang X, Wu B, Liu M. Early Prediction of Malignant Brain Edema After Ischemic Stroke. Stroke. 2018 Dec;49(12):2918-2927. doi: 10.1161/STROKEAHA.118.022001.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 12, 2017
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): August 31, 2020

Study Registration Dates

• First Submitted: July 11, 2017
• First Submitted That Met QC Criteria: July 15, 2017
• First Posted (ACTUAL): July 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: prognosis; risk factors; severe; management; malignant; clinical course; ischaemic stroke; courses
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: 2017SZ0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No