Severe Ischaemic StrokeSISNCT03222024
Cohort Study for Severe Ischaemic Stroke
An observational study of Severe Ischaemic Stroke and Malignant Ischaemic Stroke, run by West China Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Ischaemic Stroke, Malignant Ischaemic Stroke
- What is being tested?
- routine medical care
- How many people
- 2,500 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2017to 31 Aug 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Likely to be unavailable for follow-up, e.g. no fixed home address
- Refuse to give consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Being tested
- routine medical care
- Keywords
- ischaemic stroke, severe, malignant, courses, risk factors, clinical course, management, prognosis
- Medical subject headings
- Ischemic Stroke, Lymphoma, Follicular, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine medical careOther
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
| Study group | Role | What they receive |
|---|---|---|
| Severe ischaemic stroke | patients with severe stroke on admission Receives: Other: routine medical care | |
| Malignant ischaemic stroke | patients without severe stroke on admission but developing it in hospital Receives: Other: routine medical care | |
| Mild to moderate ischaemic stroke | patients without severe stroke from onset to discharge Receives: Other: routine medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome at 3 months after stroke onset
Modified Rankin scale score of patients at 3 months after the onset of ischaemic stroke.
Measured: 3 months after stroke onset
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 1 year after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start12 Sep 2017
- Primary completion31 Dec 2019
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Severe Ischaemic StrokeStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan Academy of Medical Sciences, The Affiliated Hospital Of Southwest Medical University, Affiliated Hospital of North Sichuan Medical College, Chengdu University of Traditional Chinese Medicine, Mianyang Central Hospital, People's Hospital of Deyang City, The First People's Hospital of Ziyang, Jiangyou People's Hospital, Science and Technology Department of Sichuan Province, National Natural Science Foundation of China
- Responsible party
- Principal investigator, Simiao Wu, M.D., Ph.D., West China Hospital
- Investigators
- Ming Liu, MD, Study chair, West China HospitalShihong Zhang, MD, Study director, West China HospitalSimiao Wu, MD, PhD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222024
- Sponsor's protocol ID
- 2017SZ0007
- Acronym
- SIS
- Status last verified
- Oct 2020
- First submitted
- 11 Jul 2017
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 30373783Wu 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.
PubMed 30571414Wu S, Wang Y, Yuan R, Liu M, Hua X, Huang L, Guo F, Yang D, Li Z, Wu B, Wang C, Duan J, Ling T, Zhang H, Zhang S, Wu B, Zhu C, Anderson CS, Liu M. Clinical course, causes of worsening, and outcomes of severe ischemic stroke: A prospective multicenter cohort study. Chin Med J (Engl). 2025 Jul 5;138(13):1578-1586. doi: 10.1097/CM9.0000000000003556. Epub 2025 Mar 17.
PubMed 40090964Wu S, Wang Y, Yuan R, Guo F, Yang D, Li Z, Wu B, Wang C, Duan J, Ling T, Zhang H, Zhang S, Wu B, Anderson CS, Liu M. Predicting the emergence of malignant brain oedema in acute ischaemic stroke: a prospective multicentre study with development and validation of predictive modelling. EClinicalMedicine. 2023 Apr 27;59:101977. doi: 10.1016/j.eclinm.2023.101977. eCollection 2023 May.
PubMed 37152361
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Features, Management and Outcomes of Severe Ischaemic Stroke in Tertiary Hospitals in China: a Multi-centre Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03222024
- Acronym / sponsor ID
- SIS / 2017SZ0007
- Keywords
- ischaemic stroke, severe, malignant, courses, risk factors, clinical course, management, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- Sichuan Academy of Medical Sciences, The Affiliated Hospital Of Southwest Medical University, Affiliated Hospital of North Sichuan Medical College, Chengdu University of Traditional Chinese Medicine, Mianyang Central Hospital, People's Hospital of Deyang City, The First People's Hospital of Ziyang, Jiangyou People's Hospital, Science and Technology Department of Sichuan Province, National Natural Science Foundation of China
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 19 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe ischaemic stroke | – | Other: routine medical carepatients with severe stroke on admission |
| Malignant ischaemic stroke | – | Other: routine medical carepatients without severe stroke on admission but developing it in hospital |
| Mild to moderate ischaemic stroke | – | Other: routine medical carepatients without severe stroke from onset to discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Likely to be unavailable for follow-up, e.g. no fixed home address
- Refuse to give consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| routine medical careThis 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 | Other | Malignant ischaemic stroke, Mild to moderate ischaemic stroke, Severe ischaemic stroke |
Primary outcome
Functional outcome at 3 months after stroke onset
Time frame: 3 months after stroke onset
Modified Rankin scale score of patients at 3 months after the onset of ischaemic stroke.
6 secondary outcomes
Proportion of patients with initially severe ischaemic stroke
Time frame: 24 hours after admission
Proportion of patients experiencing clinical worsening following acute ischaemic stroke
Time frame: 30 days after admission
Proportion of patients with malignant brain oedema following acute ischaemic stroke
Time frame: 30 days after admission
Clinical course of stroke severity in patients with initially severe stroke
Time frame: 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.
Time frame: 30 days after admission
Functional outcome at 1 year after stroke onset
Time frame: 1 year after stroke onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Background: PubMed 30373783Wu 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.
- Background: PubMed 30571414Wu 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.
- Derived from this study: PubMed 40090964Wu S, Wang Y, Yuan R, Liu M, Hua X, Huang L, Guo F, Yang D, Li Z, Wu B, Wang C, Duan J, Ling T, Zhang H, Zhang S, Wu B, Zhu C, Anderson CS, Liu M. Clinical course, causes of worsening, and outcomes of severe ischemic stroke: A prospective multicenter cohort study. Chin Med J (Engl). 2025 Jul 5;138(13):1578-1586. doi: 10.1097/CM9.0000000000003556. Epub 2025 Mar 17.
- Derived from this study: PubMed 37152361Wu S, Wang Y, Yuan R, Guo F, Yang D, Li Z, Wu B, Wang C, Duan J, Ling T, Zhang H, Zhang S, Wu B, Anderson CS, Liu M. Predicting the emergence of malignant brain oedema in acute ischaemic stroke: a prospective multicentre study with development and validation of predictive modelling. EClinicalMedicine. 2023 Apr 27;59:101977. doi: 10.1016/j.eclinm.2023.101977. eCollection 2023 May.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Liu, MD study chair
West China Hospital
Shihong Zhang, MD study director
West China Hospital
Simiao Wu, MD, PhD principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Ischaemic Stroke and Malignant Ischaemic Stroke, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome at 3 months after stroke onset (time frame: 3 months after stroke onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03222024, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020; AzTrials last refreshed its copy on 29 Oct 2026.