Rt-PA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke
2018年3月24日 更新者:Ji Xunming、Capital Medical University
Safety and Feasibility of Rt-PA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke(rtPA-RIC1)
The purpose of this study is to determine the safety and feasibility of remote limb ischemic conditioning(RIC) in acute ischemic stroke patients who received r-tPA thrombolytic therapy.
研究概览
研究类型
介入性
注册 (实际的)
31
阶段
- 不适用
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。
学习地点
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XI Cheng District
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Beijing、XI Cheng District、中国、100053
- Xuanwu Hospital, Capital Medical University
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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
18年 及以上 (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:
- Male or female, age≥18;
- Acute ischemic stroke;
- modified Rankin Scale (mRS) score of 2-5;
- mRS score less than 1 before onset of stroke symptom;
- Onset of stroke symptoms within 4.5h before initiation of intravenous rt-PA thrombolytic therapy;
- Good compliance for Remote Ischemic Conditioning(RIC) therapy;
- Informed consent obtained.
Exclusion Criteria:
- Stroke or serious head trauma within the previous 3 months
- Major surgery or severe trauma with in the preceding 3 months
- Intracranial hemorrhage
- Systolic pressure greater than 185 mm Hg or diastolic pressure greater than 110 mm Hg, or aggressive treatment intravenous medication) necessary to reduce blood pressure to these limits
- Symptoms rapidly improving
- Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal
- Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days
- Arterial puncture at a noncompressible site within the previous 7 days
- Seizure at the onset of stroke
- Platelet count of less than 100,000 per cubic millimeter
- Received heparin within the 48 hours preceding the onset of stroke and had an elevated partial-thromboplastin time
- Received oral anticoagulation therapy preceding the onset of stroke and INR greater than 1.7 or prothrombin times greater than 15 seconds
- CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere)
- Use or plan to use intervention for diagnosis or treating
- Intracranial neoplasm, cerebral aneurysm or arteriovenous malformation
- severe hepatic or renal dysfunction
- Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
- Life expectancy<1 years
- Pregnant or breast-feeding women
- Unwilling to be followed up or poor compliance for treatment
- Patients being enrolled or having been enrolled
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:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:Control group
The participants received r-tPA thrombolytic therapy after diagnosed ischemic stroke.
In addition, all participants receive a standard clinical therapy.
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实验性的:RIC group
The upper limb ischemic conditioning is composed of five cycles of upper limb ischemia intervened by reperfusion, which is induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation.
This therapy started within 2 hours after r-tPA thrombolytic therapy.
In addition, all participants receive a standard clinical therapy.
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In this study, the remote ischemic conditioning treatment was composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which was induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. Doctormate, IPC-906 |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Feasibility of RIC after acute ischemic stroke
大体时间:7 days
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The proportion of enrolled subjects that completed all the designed RIC procedures.
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7 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Objective signs of tissue or neurovascular injury
大体时间:within 7(±24h) days
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objective signs of tissue or neurovascular injury felt to be due to cuff inflation.
Inspection included palpation of distal radial pulses, visual inspection (for local edema, redness, skin breakdown), and palpation for tenderness
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within 7(±24h) days
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Number of participants with intracranial hemorrhage in two groups
大体时间:7(±24h)days
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7(±24h)days
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Scores assessed by National Institutes of Health Stroke Scale(NIHSS)
大体时间:7(±24h)days
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7(±24h)days
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The functional outcome at 90 days assessed by modified Rankin scale (mRS).
大体时间:90( ±7days) days
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90( ±7days) days
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functional outcome assessed by Barthel Index(BI)
大体时间:90( ±7days)days
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90( ±7days)days
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cerebral infarct volume.
大体时间:3-7 days after stroke onset
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The infarct volume of cerebral infarct is evaluated by cranial noncontrast MRI
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3-7 days after stroke onset
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cerebral infarct volume.
大体时间:3-7 days after stroke onset
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The infarct volume of cerebral infarct is evaluated by cranial noncontrast CT
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3-7 days after stroke onset
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Cardiovascular parameters during 7 days of RIC treatment.
大体时间:7 days
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the blood pressure were measured immediately before RIC and also be measured 5 minutes after RIC.
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7 days
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the heart rate during 7 days of RIC treatment.
大体时间:7 days
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the heart rate were measured immediately before RIC and also be measured 5 minutes after RIC.
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7 days
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Levels of plasma myoglobin
大体时间:baseline and 7(±2)days
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baseline and 7(±2)days
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Levels of serum IL-6
大体时间:baseline and 7(±2)days
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baseline and 7(±2)days
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Levels of serum HS-CRP
大体时间:baseline and 7(±2)days
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baseline and 7(±2)days
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Levels of serum HCY
大体时间:baseline and 7(±2)days
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baseline and 7(±2)days
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Any adverse events
大体时间:90(±7)days
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90(±7)days
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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。
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 (实际的)
2017年8月10日
初级完成 (实际的)
2017年10月30日
研究完成 (实际的)
2018年2月14日
研究注册日期
首次提交
2017年7月5日
首先提交符合 QC 标准的
2017年7月24日
首次发布 (实际的)
2017年7月27日
研究记录更新
最后更新发布 (实际的)
2018年3月27日
上次提交的符合 QC 标准的更新
2018年3月24日
最后验证
2018年3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.
Remote ischemic conditioning的临床试验
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Morgan State UniversityUniversity of Maryland, Baltimore尚未招聘