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Cohort Study for Severe Ischaemic Stroke (SIS)

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ClinicalTrials.gov Identifier: NCT03222024
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : September 14, 2017
Sponsor:
Collaborators:
Sichuan Academy of Medical Sciences &Sichuan Provincial People’s Hospital
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 & Technology Department of Sichuan Province
National Natural Science Foundation of China
Information provided by (Responsible Party):
Simiao Wu, M.D., Ph.D., West China Hospital

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).

Condition or disease Intervention/treatment
Severe Ischaemic Stroke Malignant Ischaemic Stroke 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 [Patient Registry]
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Clinical Features, Management and Outcomes of Severe Ischaemic Stroke in Tertiary Hospitals in China: a Multi-centre Prospective Observational Study
Actual Study Start Date : September 12, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Proportion of patients with initially severe ischaemic stroke [ Time Frame: 24 hours after admission ]
    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.

  2. Proportion of patients experiencing clinical worsening following acute ischaemic stroke [ Time Frame: 30 days after admission ]
    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.

  3. Proportion of patients with malignant brain oedema following acute ischaemic stroke [ Time Frame: 30 days after admission ]
    Malignant brain oedema is defined as symptoms or signs of clinical worsening associated with imaging evidence of space-occupying brain oedema.

  4. Clinical course of stroke severity in patients with initially severe stroke [ Time Frame: 30 days after admission ]
    Dynamically record scores of National Institute of Health Stroke Scale (NIHSS) from day 0, day 3, day 7 to day 30 after admission.

  5. 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 ]
    Dynamically record scores of Glasgow Coma Scale (GCS)

  6. Functional outcome at 1 year after stroke onset [ Time Frame: 1 year after stroke onset ]
    Modified Rankin scale score of patients at 1 year after the onset of ischaemic stroke.


Biospecimen Retention:   Samples With DNA
We will collect blood samples from patients with their written consent


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222024


Contacts
Contact: Simiao Wu, MD, PhD +86 28 85422833 simiao.wu@hotmail.com
Contact: Ruozhen Yuan, MSc +86 28 85422833 yuanrz822@sina.com

Locations
China, Sichuan
West China Hospital, Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact: Simiao Wu, MD, PhD    +86 28 85422833    simiao.wu@hotmail.com   
Contact: Ruozhen Yuan, MSc    +86 28 85422833    yuanrz822@sina.com   
Principal Investigator: Simiao Wu, MD, PhD         
Sub-Investigator: Ruozhen Yuan, MSc         
Sponsors and Collaborators
West China Hospital
Sichuan Academy of Medical Sciences &Sichuan Provincial People’s Hospital
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 & Technology Department of Sichuan Province
National Natural Science Foundation of China
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

Responsible Party: Simiao Wu, M.D., Ph.D., Dr, West China Hospital
ClinicalTrials.gov Identifier: NCT03222024     History of Changes
Other Study ID Numbers: 2017SZ0007
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Simiao Wu, M.D., Ph.D., West China Hospital:
ischaemic stroke
severe
malignant
courses
risk factors
clinical course
management
prognosis

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia