Department of Neurology, Shanghai Pudong Hospital, Fudan University, Shanghai, China.
Department of Internal Medicine, Maharajgunj Medical Campus, Tribhuvan University Institute of Medicine, Kathmandu, Nepal.
BMJ Open. 2022 Nov 10;12(11):e060818. doi: 10.1136/bmjopen-2022-060818.
Wake-up stroke (WUS) is a type of acute ischaemic stroke (AIS) that occurs during sleep with unknown time of symptom onset. The best treatment is usually not suitable for WUS, as thrombolysis is usually provided to patients who had a symptomatic AIS within a definite 4.5 hours, and WUS remains a therapeutic quandary. Efforts to explore the onset time characteristics of patients who had a WUS and the risk factors affecting poor prognosis support a role for providing new insights by performing multicentre cohort study.
This multicentre, nationwide prospective registry will include 21 comprehensive stroke centres, with a goal of recruiting 550 patients who had a WUS in China. In this study, clinical data including patient's clinical characteristics, stroke onset time, imaging findings, therapeutic interventions and prognosis (the National Institutes of Health Stroke Scale Score and the modified Rankin Scale Score at different time points) will be used to develop prediction models for stroke onset time and prognostic evaluation using the fast-processing of ischemic stroke software. The purpose of this study is to identify risk factors influencing prognosis, to investigate the relationship between the time when the symptoms are found and the actual onset time and to establish an artificial intelligence-based model to predict the prognosis of patients who had a WUS.
This study is approved by the ethics committee of Shanghai Pudong Hospital (Shanghai, China) and rest of all participating centres. The findings will be disseminated through peer-reviewed publications and conference presentations.
ChiCTR2100049133.
觉醒型卒中（WUS）是一种在睡眠中发生的急性缺血性卒中（AIS），其症状起始时间未知。最佳治疗方法通常不适合 WUS，因为溶栓通常提供给在明确的 4.5 小时内发生症状性 AIS 的患者，而 WUS 仍然是一个治疗难题。探索 WUS 患者发病时间特征和影响不良预后的风险因素的努力，支持通过进行多中心队列研究提供新见解的作用。
本项多中心、全国性前瞻性注册研究将纳入 21 家综合卒中中心，目标是在中国招募 550 例 WUS 患者。在这项研究中，临床数据包括患者的临床特征、卒中发病时间、影像学发现、治疗干预和预后（不同时间点的国立卫生研究院卒中量表评分和改良 Rankin 量表评分）将用于开发使用缺血性卒中快速处理软件进行卒中发病时间和预后评估的预测模型。本研究的目的是确定影响预后的风险因素，研究发现症状时间与实际发病时间之间的关系，并建立基于人工智能的模型来预测 WUS 患者的预后。
本研究已获得上海浦东医院（中国上海）和所有参与中心的伦理委员会的批准。研究结果将通过同行评议的出版物和会议报告进行传播。
ChiCTR2100049133。
