Clinical trial NCT03222024: Cohort Study for Severe Ischaemic Stroke
Official title: Clinical Features, Management and Outcomes of Severe Ischaemic Stroke in Tertiary Hospitals in China: a Multi-centre Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Ischaemic Stroke
Malignant Ischaemic Stroke
Keywords: ischaemic stroke
severe
malignant
courses
risk factors
clinical course
management
prognosis
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: Sichuan Academy of Medical Sciences
name: The Affiliated Hospital Of Southwest Medical University
name: Afﬁliated Hospital of North Sichuan Medical College
name: Chengdu University of Traditional Chinese Medicine
name: Mianyang Central Hospital
name: People's Hospital of Deyang City
name: The First People's Hospital of Ziyang
name: Jiangyou People's Hospital
name: Science and Technology Department of Sichuan Province
name: National Natural Science Foundation of China
First posted: 2017-07-19
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility 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

Primary outcomes:
measure: Functional outcome at 3 months after stroke onset
timeFrame: 3 months after stroke onset
Secondary outcomes:
measure: Proportion of patients with initially severe ischaemic stroke
timeFrame: 24 hours after admission
measure: Proportion of patients experiencing clinical worsening following acute ischaemic stroke
timeFrame: 30 days after admission
measure: Proportion of patients with malignant brain oedema following acute ischaemic stroke
timeFrame: 30 days after admission
measure: Clinical course of stroke severity in patients with initially severe stroke
timeFrame: 30 days after admission
measure: Changes in consicousness level of patients with initially severe stroke from day 0, day 3, day 7 to day 30 after admission.
timeFrame: 30 days after admission
measure: Functional outcome at 1 year after stroke onset
timeFrame: 1 year after stroke onset
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Ming Liu, MD
role: STUDY_CHAIR
affiliation: West China Hospital
name: Shihong Zhang, MD
role: STUDY_DIRECTOR
affiliation: West China Hospital
name: Simiao Wu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.