MR CLEAN, a multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke in the Netherlands: study protocol for a randomized controlled trial.
MR CLEAN, a multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke in the Netherlands: study protocol for a randomized controlled trial.
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MR CLEAN，荷兰一项急性缺血性中风血管内治疗的多中心随机临床试验：随机对照试验的研究方案。
DOI：
10.1186/1745-6215-15-343
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发表时间：
2014-09-01
期刊：
影响因子：
2.5
通讯作者：
MR CLEAN Investigators
中科院分区：
文献类型：
--
作者：
Fransen PS;Beumer D;Berkhemer OA;van den Berg LA;Lingsma H;van der Lugt A;van Zwam WH;van Oostenbrugge RJ;Roos YB;Majoie CB;Dippel DW;MR CLEAN Investigators
血管内或动脉内治疗（IAT）增加了近端颅内动脉闭塞引起的急性缺血性卒中患者再通的可能性。然而，IAT对急性缺血性中风患者功能恢复的有益作用尚未得到证实。本研究的目的是评估IAT对急性缺血性卒中患者功能结局的影响。此外，我们旨在评估IAT的安全性，以及不同机械治疗方式对再通的影响。一项盲态结局评估的多中心随机临床试验。活动比较是IAT与无IAT。IAT可能包括阿替普酶或尿激酶动脉内溶栓、机械治疗或两者兼而有之。机械治疗是指回撤、抽吸、超声溶解或使用可回收支架（支架取栓器）。有相关前循环颅内近端动脉闭塞的患者，可在卒中发作后6小时内接受治疗，符合条件。将使用有序逻辑回归（偏移分析）估计治疗效果;试验将纳入500例患者，把握度为80%，以检测导致10%治疗患者依赖性降低的偏移。主要结局是90天时改良兰金量表评分。次要结局是24小时的国立卫生研究院卒中量表评分、24小时的血管通畅率、第5天的梗死面积和前5天的大出血发生率。如果IAT导致卒中后不良结局的绝对减少10%，则仔细实施干预措施每年可使所有新发卒中病例中约1%免于死亡或残疾。NTR 1804（2009年5月7日）/ISRCTN 10888758（2012年7月24日）。本文的在线版本（doi：10.1186/1745-6215-15-343）包含补充材料，可供授权用户使用。
Endovascular or intra-arterial treatment (IAT) increases the likelihood of recanalization in patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion. However, a beneficial effect of IAT on functional recovery in patients with acute ischemic stroke remains unproven. The aim of this study is to assess the effect of IAT on functional outcome in patients with acute ischemic stroke. Additionally, we aim to assess the safety of IAT, and the effect on recanalization of different mechanical treatment modalities. A multicenter randomized clinical trial with blinded outcome assessment. The active comparison is IAT versus no IAT. IAT may consist of intra-arterial thrombolysis with alteplase or urokinase, mechanical treatment or both. Mechanical treatment refers to retraction, aspiration, sonolysis, or use of a retrievable stent (stent-retriever). Patients with a relevant intracranial proximal arterial occlusion of the anterior circulation, who can be treated within 6 hours after stroke onset, are eligible. Treatment effect will be estimated with ordinal logistic regression (shift analysis); 500 patients will be included in the trial for a power of 80% to detect a shift leading to a decrease in dependency in 10% of treated patients. The primary outcome is the score on the modified Rankin scale at 90 days. Secondary outcomes are the National Institutes of Health stroke scale score at 24 hours, vessel patency at 24 hours, infarct size on day 5, and the occurrence of major bleeding during the first 5 days. If IAT leads to a 10% absolute reduction in poor outcome after stroke, careful implementation of the intervention could save approximately 1% of all new stroke cases from death or disability annually. NTR1804 (7 May 2009)/ISRCTN10888758 (24 July 2012). The online version of this article (doi:10.1186/1745-6215-15-343) contains supplementary material, which is available to authorized users.
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影响因子：
158.5
作者：
Hacke, Werner;Kaste, Markku;Toni, Danilo
通讯作者：
Toni, Danilo
DOI：
10.1056/nejmoa1214300
发表时间：
2013-03-07
期刊：
The New England journal of medicine
影响因子：
--
作者：
Broderick JP;Palesch YY;Demchuk AM;Yeatts SD;Khatri P;Hill MD;Jauch EC;Jovin TG;Yan B;Silver FL;von Kummer R;Molina CA;Demaerschalk BM;Budzik R;Clark WM;Zaidat OO;Malisch TW;Goyal M;Schonewille WJ;Mazighi M;Engelter ST;Anderson C;Spilker J;Carrozzella J;Ryckborst KJ;Janis LS;Martin RH;Foster LD;Tomsick TA;Interventional Management of Stroke (IMS) III Investigators
通讯作者：
Interventional Management of Stroke (IMS) III Investigators
DOI：
10.1016/s0197-2456(97)00012-3
发表时间：
1997-08-01
期刊：
CONTROLLED CLINICAL TRIALS
影响因子：
--
作者：
Adams, HP;Woolson, RF;Grimsman, KJ
通讯作者：
Grimsman, KJ
影响因子：
8.3
作者：
Heldner, Mirjam R.;Zubler, Christoph;Fischer, Urs
通讯作者：
Fischer, Urs
DOI：
10.1056/nejmoa1212793
发表时间：
2013-03-07
期刊：
The New England journal of medicine
影响因子：
--
作者：
Kidwell CS;Jahan R;Gornbein J;Alger JR;Nenov V;Ajani Z;Feng L;Meyer BC;Olson S;Schwamm LH;Yoo AJ;Marshall RS;Meyers PM;Yavagal DR;Wintermark M;Guzy J;Starkman S;Saver JL;MR RESCUE Investigators
通讯作者：
MR RESCUE Investigators