RATIONALE Although mild and rapidly improving stroke symptoms are the most common first stroke presentation, this group has been understudied in acute stroke trials. Observational and retrospective studies suggest residual disability in one third of patients. AIMS To elucidate long-term outcomes of patients with mild and rapidly improving stroke, evaluate the predictors of outcome, and examine the association with alteplase treatment. SAMPLE SIZE The initial estimate of 2650 participants to detect a 9% difference in non-disabled 90-day outcomes between alteplase-treated and untreated participants was revised to 2000 after a pre-planned re-estimation based on actual treatment rates. METHODS AND DESIGN Prospective observational study of patients with mild ischemic stroke (NIHSS ≤ 5) or rapidly improving stroke symptoms evaluated within 4.5 h from onset. OUTCOMES The primary outcome is the proportion of patients with modified Rankin Scale (mRS) ≥ 2 at 90 days; the primary safety outcome is symptomatic hemorrhagic transformation within 36 h among those treated with alteplase. Secondary outcomes include the 90-day Barthel Index, Stroke Impact Scale 16, European Quality of Life scale, mRS at 30 days, and 30- and 90-day mortality. DISCUSSION MaRISS will define outcomes and their predictors and clarify the effects of alteplase in patients with mild and rapidly improving stroke symptoms, providing clinicians with important information to manage this population.

中文翻译：

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轻度和快速改善卒中研究（MaRISS）：基本原理和设计。

理由尽管轻度和快速改善的中风症状是最常见的首发中风症状，但该组在急性中风试验中并未得到充分研究。观察和回顾性研究表明，三分之一的患者存在残障。目的阐明轻度和快速好转的卒中患者的长期预后，评估预后的预测因素，并检查与阿替普酶治疗的相关性。样本大小为了检测出接受阿替普酶治疗的参与者和未经治疗的参与者之间90天的非残疾90天结果之间存在9％的差异，最初的2650名参与者的初始估计在根据实际治疗率进行了预先计划的重新估计后，被修订为2000年。方法和设计对轻度缺血性中风（NIHSS≤5）或快速改善中风症状的患者进行前瞻性观察研究，评估结果在4内评估。发病5小时。结果主要结果是在90天时兰金评分（mRS）≥2的患者所占比例；主要的安全性结局是使用阿替普酶治疗的患者在36小时内出现症状性出血性转化。次要结果包括90天Barthel指数，中风影响量表16，欧洲生活质量量表，30天时的mRS以及30天和90天死亡率。讨论MaRISS将确定结果及其预测指标，并阐明阿替普酶对轻度和快速改善的中风症状患者的影响，为临床医生提供重要信息以管理这一人群。主要的安全性结局是使用阿替普酶治疗的患者在36小时内出现症状性出血性转化。次要结果包括90天Barthel指数，中风影响量表16，欧洲生活质量量表，30天时的mRS以及30天和90天死亡率。讨论MaRISS将确定结果及其预测指标，并阐明阿替普酶对轻度和快速改善的中风症状患者的影响，为临床医生提供重要信息以管理这一人群。主要的安全性结局是使用阿替普酶治疗的患者在36小时内出现症状性出血性转化。次要结果包括90天Barthel指数，中风影响量表16，欧洲生活质量量表，30天时的mRS以及30天和90天死亡率。讨论MaRISS将确定结果及其预测指标，并阐明阿替普酶对轻度和快速改善的中风症状患者的影响，为临床医生提供重要信息以管理这一人群。