Cohort Study for Severe Ischaemic Stroke

NCT03222024 | Completed DMC

• 1 other identifier: 2017SZ0007
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Severe Ischaemic Stroke; Malignant Ischaemic Stroke

Keywords

ischaemic stroke; severe; malignant; courses; risk factors; clinical course; management; prognosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Proportion of patients with initially severe ischaemic stroke

  24 hours after admission

• Proportion of patients experiencing clinical worsening following acute ischaemic stroke

  30 days after admission

• Proportion of patients with malignant brain oedema following acute ischaemic stroke

  30 days after admission

• Clinical course of stroke severity in patients with initially severe stroke

  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.

  30 days after admission

Study Arms (3)

Severe ischaemic stroke

patients with severe stroke on admission

Other: routine medical care

Malignant ischaemic stroke

patients without severe stroke on admission but developing it in hospital

Other: routine medical care

Mild to moderate ischaemic stroke

patients without severe stroke from onset to discharge

Other: routine medical care

Interventions

routine medical care 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; Mild to moderate ischaemic stroke; Severe ischaemic stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Likely to be unavailable for follow-up, e.g. no fixed home address
• Refuse to give consent to participate

Sponsors & Collaborators

• West China Hospital: lead
• Sichuan Academy of Medical Sciences: collaborator
• The Affiliated Hospital Of Southwest Medical University: collaborator
• Affiliated Hospital of North Sichuan Medical College: collaborator
• Chengdu University of Traditional Chinese Medicine: collaborator
• Mianyang Central Hospital: collaborator
• People's Hospital of Deyang City: collaborator
• The First People's Hospital of Ziyang: collaborator
• Jiangyou People's Hospital: collaborator
• Science and Technology Department of Sichuan Province: collaborator
• National Natural Science Foundation of China: collaborator

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (4)

• 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.

  PMID: 30373783 BACKGROUND

• 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.

  PMID: 30571414 BACKGROUND

• 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.

  PMID: 40090964 DERIVED

• 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.

  PMID: 37152361 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

We will collect blood samples from patients with their written consent

MeSH Terms

Conditions

Ischemic Stroke; Lymphoma, Follicular; Disease Progression

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ming Liu, MD

  West China Hospital

  STUDY CHAIR

• Shihong Zhang, MD

  West China Hospital

  STUDY DIRECTOR

• Simiao Wu, MD, PhD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 19, 2017
• Study Start: September 12, 2017
• Primary Completion: December 31, 2019
• Study Completion: August 31, 2020
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

CN (1)