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Cohort Study for Severe Ischaemic Stroke

NCT ID: NCT03222024

Last Updated: 2020-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-12

Study Completion Date

2020-08-31

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.

Conditions

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Severe Ischaemic Stroke Malignant Ischaemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Severe ischaemic stroke

patients with severe stroke on admission

routine medical care

Intervention Type OTHER

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

routine medical care

Intervention Type OTHER

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

routine medical care

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sichuan Academy of Medical Sciences

OTHER

Sponsor Role collaborator

The Affiliated Hospital Of Southwest Medical University

OTHER

Sponsor Role collaborator

Affiliated Hospital of North Sichuan Medical College

OTHER

Sponsor Role collaborator

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Mianyang Central Hospital

OTHER

Sponsor Role collaborator

People's Hospital of Deyang City

UNKNOWN

Sponsor Role collaborator

The First People's Hospital of Ziyang

UNKNOWN

Sponsor Role collaborator

Jiangyou People's Hospital

UNKNOWN

Sponsor Role collaborator

Science and Technology Department of Sichuan Province

OTHER

Sponsor Role collaborator

National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Simiao Wu, M.D., Ph.D.

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ming Liu, MD

Role: STUDY_CHAIR

West China Hospital

Shihong Zhang, MD

Role: STUDY_DIRECTOR

West China Hospital

Simiao Wu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

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West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 30373783 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30571414 (View on PubMed)

Wu 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.

Reference Type DERIVED
PMID: 40090964 (View on PubMed)

Wu 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.

Reference Type DERIVED
PMID: 37152361 (View on PubMed)

Other Identifiers

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2017SZ0007

Identifier Type: -

Identifier Source: org_study_id