Penumbra and re-canalization acute computed tomography in ischemic stroke evaluation: PRACTISE study protocol
Penumbra and re-canalization acute computed tomography in ischemic stroke evaluation: PRACTISE study protocol
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DOI：
10.1177/1747493017696099
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发表时间：
2017-08-01
影响因子：
6.7
通讯作者：
Muir, Keith W.
中科院分区：
文献类型：
--
作者：
El-Tawil, Salwa;Wardlaw, Joanna;Muir, Keith W.
基本原理：多模式成像，包括计算机断层扫描血管造影和计算机断层扫描灌注成像，可以提供颅内血管和脑灌注的额外信息，并可以区分缺血核心区和半暗带，这可能会影响静脉溶栓患者的选择。假设：多模式成像的使用将增加接受静脉溶栓的患者数量，并导致更好的治疗结果。样本量：方法和设计：PRACTISE是一项前瞻性、多中心、随机、对照试验，其中症状发作4.5小时内出现的患者随机接受当前循证成像（单独NCCT）或额外的多模式计算机断层扫描成像（NCCT +计算机断层扫描血管造影术+计算机断层扫描灌注）。静脉注射重组组织型纤溶酶原激活剂的临床决策被记录。记录两组中的总成像时间和用静脉内重组组织纤溶酶原激活剂治疗的那些患者中至开始治疗递送的时间。随访将包括24小时的脑成像，以记录梗死面积、是否存在水肿和是否存在脑内出血。临床评价包括基线、24 h和第7 +/- 2天的NIHSS评分，以及第90天的mRS，以确定功能结局。次要终点评估时间的决策，比较不同的图像处理软件和临床outcomes at three months.Discussion：多模式计算机断层扫描是一种广泛使用的工具，为患者选择血运重建治疗，但目前尚不清楚是否使用额外的成像在所有中风患者是有益的。该研究于2015年3月开始招募，并将提供多模式成像在急性卒中治疗决策中的价值数据。
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.