Ultrasound Enhanced Thrombolytic Therapy of Middle Cerebral Artery Occlusion
2007年4月25日 更新者:University of Zurich
Transcranial Ultrasound Enhanced Thrombolysis (TRUST)
The purpose of the present, randomized, controlled multicenter phase III trial is to investigate the safety and efficacy of continuous 1-hour insonation of occluded middle cerebral artery with 2 MHz TCCS in stroke patients treated with intravenous tissue plasminogen activator (t-PA) within 3 hours after symptom onset.
研究概览
详细说明
Thrombolysis with intravenous(iv) tissue plasminogen activator (t-PA) is the only effective and approved therapy for acute ischemic stroke.
The most frequent cause of ischemic stroke is thrombosis of the middle cerebral artery (MCA).
Preliminary in vitro, animal and human studies suggest that ultrasound accelerates thrombolysis induced by t-PA, and recanalization of acute MCA occlusion due to thrombolysis is an independent predictor of good clinical outcome.
Thus, insonation of an occluded MCA through the temporal bone in stroke patients who are treated with iv t-PA might enhance recanalization and improve clinical outcome.
The present prospective, randomized, controlled multicenter pilot study will investigate the safety and efficacy of continuous 1-hour insonation of the occluded MCA with 2 MHz transcranial color duplex sonography in patients with ischemic stroke treated with iv t-PA within 3 hours after symptom onset.
It is planned to randomize 400 patients in 6 Swiss centers during an enrolment period of 33 months with an individual follow up of 3 months.
The study endpoints include safety and efficacy assessments.
The primary safety endpoint is to determine the rate of symptomatic intracranial hemorrhage (ICH) in both treatment groups.
The primary efficacy endpoint is to determine whether a good functional outcome (modified Rankin scale, mRs, score of 0-2) differs between both treatment groups.
Secondary endpoints include (1) asymptomatic ICH occuring during or within the first 24-48 hours after t-PA infusion, (2) early clinical recovery by 10 or more National Institute of Health Stroke Scale (NIHSS) points or dramatic recovery (total NIHSS score of 3 or less) at 24-48 hours after t-PA infusion, (3) mean mRS score at 90 days after t-PA infusion, (4) death occuring during the study period, and (5) recanalization at 24-48 hours after t-PA infusion.
研究类型
介入性
注册
400
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Ralf W Baumgartner, MD
- 电话号码:+41 1 255 56 86
- 邮箱:ralf.baumgartner@usz.ch
学习地点
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-
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Aarau、瑞士
- 招聘中
- Kantonsspital Aarau, Department of Neurology
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接触:
- Hansjörg Hungerbühler, MD
- 电话号码:+41 62 838 66 75
- 邮箱:hansjoerg.hungerbuehler@ksa.ch
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首席研究员:
- Hansjörg Hungerbühler, MD
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Basel、瑞士
- 招聘中
- University Hospital of Basel, Department of Neurology
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接触:
- Stefan Engelter, MD
- 电话号码:+41 61 265 25 25
- 邮箱:sengelter@uhbs.ch
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首席研究员:
- Philippe Lyrer, MD
-
首席研究员:
- Stefan Engelter, MD
-
Bern、瑞士
- 招聘中
- University hospital of Bern, Department of Neurology
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接触:
- Marcel Arnold, MD
- 电话号码:+41 31 632 33 32
- 邮箱:marcel.arnold@insel.ch
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首席研究员:
- H.-P. Mattle, MD
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首席研究员:
- Marcel Arnold, MD
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Geneva、瑞士
- 招聘中
- University Hospital of Geneva, Department of Neurology
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接触:
- Roman Sztajzel, MD
- 电话号码:+41 22 372 83 10
- 邮箱:Roman.Sztajzel@hcuge.ch
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首席研究员:
- Roman Sztajzel, MD
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Lausanne、瑞士
- 招聘中
- University Hospital of Lausanne, Department of Neurology
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接触:
- Patrik Michel, MD
- 电话号码:+41 21 314 11 85
- 邮箱:patrik.michel@chuv.hospvd.ch
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首席研究员:
- Patrik Michel, MD
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Zurich、瑞士、8091
- 招聘中
- University Hospital of Zurich, Department of Neurology
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接触:
- Ralf W Baumgartner, MD
- 电话号码:+41 1 255 56 86
- 邮箱:ralf.baumgartner@usz.ch
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接触:
- Dimitrios Georgiadis, MD
- 邮箱:dimitrios.georgiadis@usz.ch
-
首席研究员:
- Ralf W Baumgartner, MD
-
首席研究员:
- Dimitrios Georgiadis, MD
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副研究员:
- Hakan Sarikaya, MD
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- acute ischemic stroke in the MCA territory according to clinical and cranial computed tomography (CT) or cranial MR imaging (MRI) findings
- patient undergoing iv thrombolysis with t-PA within 3 hours after stroke onset
- Occlusion of sphenoidal (M1) or insular (M2) segment of the MCA at CT (CTA), MR (MRA) or catheter (CA) angiography
- appropriate temporal bony window without echocontrast agents for insonation with TCCS
- full functional independence prior to present stroke (mRS 0-1), use of a cane for walking due to comorbid condition is acceptable
- written informed consent, signed and dated by the subject (or subject's authorized representative, if allowed by local laws) and by the person obtaining the consent, indicating agreement to comply with all protocol-specific procedures
Exclusion Criteria:
- unconsciousness (more than 2 points on item 1a on NIHSS)
- history of intracranial hemorrhage, arteriovenous malformation or aneurysm
- severe cranio-cerebral trauma within the last 3 months
- symptoms of subarachnoidal hemorrhage
- time of symptom onset unclear
- large surgical intervention or trauma within the last 10 days
- expected survival below 90 days after iv t-PA treatment
- severe hepatic disease, esophageal varices, acute pancreatitis
- septic embolism, endocarditis, pericarditis after myocardial infarction
- pregnancy or childbirth within the last 30 days or nursing mothers
- history of hemorrhagic diathesis or coagulopathy
- untreatable increase of arterial blood pressure (>185mmHg systolic, >110mmHg diastolic)
- intracranial hemorrhage, arteriovenous malformations or aneurysm at brain imaging
- thrombocytes <100'000 per microliter
- international normalized ratio (INR)>1.7 or partial thromboplastin time (PTT) prolongated
- serum glucose <2.7mmol/l or >22.2mmol/l
- severe renal insufficiency or other contraindications against CT-contrast agents
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
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Symptomatic intracranial hemorrhage (safety)
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Functional outcome (efficacy)
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次要结果测量
结果测量 |
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Asymptomatic intracranial hemorrhage 24-48 hours after t-PA infusion
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Early clinical recovery by 10 or more NIHSS points or dramatic recovery (total NIHSS 3 or less)at 24-48 hours after t-PA infusion
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Mean mRS score at 90 days after t-PA infusion
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Death occurring during study period
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Recanalization at 24-48 hours after t-PA infusion
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅:Ralf W Baumgartner, MD、University Hospital of Zurich, Department of Neurology, Zurich, Switzerland
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2006年6月1日
研究完成 (预期的)
2009年6月1日
研究注册日期
首次提交
2006年6月13日
首先提交符合 QC 标准的
2006年6月13日
首次发布 (估计)
2006年6月14日
研究记录更新
最后更新发布 (估计)
2007年4月27日
上次提交的符合 QC 标准的更新
2007年4月25日
最后验证
2007年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.