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首页> 外文期刊>Journal of stroke and cerebrovascular diseases: The official journal of National Stroke Association >Unwitnessed stroke: Impact of different onset times on eligibility into stroke trials
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Unwitnessed stroke: Impact of different onset times on eligibility into stroke trials

机译：无见证的中风：不同发作时间对中风试验资格的影响

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摘要

Background: Patients with unwitnessed stroke represent >25% of all strokes. Clinical trials enrolling patients with unwitnessed stroke onset have conservatively used last known normal (LKN) as the time of stroke onset. We explored the impact of alternative methods of selecting onset time in unwitnessed strokes on eligibility into an acute stroke therapeutic trial using a representative sample of acute stroke subjects. Methods: We analyzed data on 641 consecutive patients with suspected stroke presenting to our hospital between January 2007 and July 2008. Time of onset was calculated by 3 methods: (1) LKN, (2) first known abnormal (FKA), and (3) midpoint between LKN and FKA. Subjects with incomplete data or a final diagnosis of nonischemic stroke were excluded. Rates of trial eligibility based on different onset times were compared for several inclusion time windows. Results: Onset time was known in 440 subjects (69%). Of the remaining 201 patients with unwitnessed onset, 114 (57%) were "wake-up" strokes. Among unwitnessed stroke subjects, eligibility increased from 18% using LKN to 57% using FKA at 4.5 hours and 42% to 81% at 9 hours (P <.001), respectively. Overall enrollment eligibility for the full cohort increased from 36% to 48% at 4.5 hours and 61% to 73% at 9 hours (P <.001), respectively. Conclusion: Given potential advantages in safety evaluation and the historical inadequate enrollment rates in acute stroke trials, alternative onset time definitions, perhaps in combination with advanced neuroimaging methods (e.g., fluid-attenuated inversion recovery-diffusion-weighted imaging mismatch), should be considered for early-phase trials.
机译：背景：中风无证患者占所有中风的25％以上。招募无证卒中患者的临床试验保守地使用最近已知的正常（LKN）作为卒中发生时间。我们探讨了使用无代表性的卒中患者的代表性样本，选择无见证的卒中发作时间的替代方法对资格入急性卒中治疗试验的影响。方法：我们分析了2007年1月至2008年7月在我院就诊的641例疑似中风的连续患者的数据。发病时间通过3种方法计算：（1）LKN，（2）首次已知异常（FKA）和（3 ）在LKN和FKA之间的中点。数据不完整或最终诊断为非缺血性中风的受试者被排除在外。在几个纳入时间窗内，比较了基于不同发作时间的试验合格率。结果：440名受试者（69％）的发病时间已知。在其余201名目击者中，有114名（57％）为“醒”中风。在无证的中风受试者中，合格率分别从使用LKN的18％增加到使用FKA的57％（在4.5小时时）和从42％（在9小时时达到81％）（P <.001）。整个队列的整体入学资格在4.5小时时从36％增加到48％，在9小时时从61％增加到73％（P <.001）。结论：鉴于安全性评估的潜在优势以及急性中风试验的历史入学率不足，应考虑替代性的发病时间定义，可能与先进的神经影像学方法（例如，液体衰减倒置恢复-扩散加权成像不匹配）结合使用用于早期试验。

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