1 Institute of Neuroscience & Psychology, Queen Elizabeth University Hospital, University of Glasgow, Glasgow, UK.
2 Division of Neuroimaging Sciences, Western General Hospital, Edinburgh, University of Edinburgh, Edinburgh, UK.
Int J Stroke. 2017 Aug;12(6):671-678. doi: 10.1177/1747493017696099. Epub 2017 Mar 14.
Rationale Multimodal imaging, including computed tomography angiography and computed tomography perfusion imaging, yields additional information on intracranial vessels and brain perfusion and can differentiate between ischemic core and penumbra which may affect patient selection for intravenous thrombolysis. Hypothesis The use of multimodal imaging will increase the number of patients receiving intravenous thrombolysis and lead to better treatment outcomes. Sample size 400 patients. Methods and design PRACTISE is a prospective, multicenter, randomized, controlled trial in which patients presenting within 4.5 h of symptom onset are randomized to either the current evidence-based imaging (NCCT alone) or additional multimodal computed tomography imaging (NCCT + computed tomography angiography + computed tomography perfusion). Clinical decisions on intravenous recombinant tissue plasminogen activator are documented. Total imaging time in both arms and time to initiation of treatment delivery in those treated with intravenous recombinant tissue plasminogen activator, is recorded. Follow-up will include brain imaging at 24 h to document infarct size, the presence of edema and the presence of intra-cerebral hemorrhage. Clinical evaluations include NIHSS score at baseline, 24 h and day 7 ± 2, and mRS at day 90 to define functional outcomes. Study outcomes The primary outcome is the proportion of patients receiving intravenous recombinant tissue plasminogen activator. Secondary end-points evaluate times to decision-making, comparison of different image processing software and clinical outcomes at three months. Discussion Multimodal computed tomography is a widely available tool for patient selection for revascularization therapy, but it is currently unknown whether the use of additional imaging in all stroke patients is beneficial. The study opened for recruitment in March 2015 and will provide data on the value of multimodal imaging in treatment decisions for acute stroke.
原理 多模态成像，包括计算机断层血管造影和计算机断层灌注成像，提供了颅内血管和脑灌注的额外信息，并可以区分缺血核心和半影区，这可能会影响静脉溶栓治疗的患者选择。 假设 使用多模态成像将增加接受静脉溶栓治疗的患者数量，并带来更好的治疗效果。 样本量 400 例患者。 方法和设计 PRACTISE 是一项前瞻性、多中心、随机、对照试验，纳入症状发作 4.5 小时内的患者，随机分为现行基于证据的影像学检查（仅 NCCT）或额外的多模态计算机断层成像（NCCT+计算机断层血管造影+计算机断层灌注）。记录静脉注射重组组织型纤溶酶原激活剂的临床决策。记录两个臂的总成像时间和接受静脉注射重组组织型纤溶酶原激活剂治疗的患者开始治疗的时间。随访包括 24 小时脑成像以记录梗死灶大小、水肿存在和颅内出血存在。临床评估包括基线、24 小时和第 7 天±2 天的 NIHSS 评分以及第 90 天的 mRS 以定义功能结局。 研究结果 主要结局是接受静脉注射重组组织型纤溶酶原激活剂的患者比例。次要终点评估决策时间、不同图像处理软件的比较和三个月时的临床结局。 讨论 多模态计算机断层扫描是一种广泛用于选择血管再通治疗患者的工具，但目前尚不清楚在所有脑卒中患者中使用额外成像是否有益。该研究于 2015 年 3 月开始招募患者，将提供多模态成像在急性脑卒中治疗决策中的价值数据。
