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NCT Number: NCT03222024

Cohort Study for Severe Ischaemic Stroke

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SIS

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jul 19, 2017
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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