Intravenous Rt-PA Thrombolysis Combined With Remote Ischemic Post-Conditioning for Acute Ischemic Stroke Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- infarction volume in brain between two groups
研究概览
简要总结
to detect the efficiency and safety of intravenous rtPA combined with RIPC in acute ischemic stroke patients
详细描述
Remote ischemic post-conditioning, which consists of several brief cycles of intermittent ischemia-reperfusion of the arm or leg, may potentially confer a powerful systemic protection against prolonged ischemia in a distant organ. Numerous reports have confirmed it strongest endogenous neuroprotection against brain injury after stroke. Ren et al demonstrated that remote ischemic post-conditioning (RIPC) performed in the hind limbs can not only significantly reduce the stroke volume within 3 hours in rat model, but also ameliorate the outcome of the behavioral test. A long-term repeated RIPC therapy can also help improving neurological functions. A combination of RIPC and tPA can help with neuroprotection which improves the neurological functions. Thus, it is meaningful to transform these basic experimental results to the clinical treatment. In the RECAST-1 trial, RIC has shown it safety and efficiency in AIS patients without tPA. However, there is no further explanation for the patients with IVT. Thus, in this study, we aim to demonstrate the efficiency and safety of RIPC in AIS patients performed rt-PA within 4.5 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age≥18;
- •Clinical sign and symptoms consistent with the diagnosis of an acute ischemic stroke, onset of stroke symptoms within 4.5 h before initiation of intravenous rt-PA thrombolytic therapy;
- •Baseline National Institutes of Health Stroke Scale (NIHSS) score of 4-15 (assessed before intravenous alteplase), mRS ≤1 before onset of stroke symptom;
- •No contraindication for MRI.
- •Informed consent obtained
排除标准
- •Cardioembolism；
- •Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs;
- •Life expectancy < 1 year;
- •Pregnant or breast-feeding women;
- •Unwilling to be followed up or poor compliance for treatment; (5) Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.
研究组 & 干预措施
RIC group
The upper limb ischemic conditioning is composed of five cycles of bilateral 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.
干预措施: ischemic conditioning (Device)
Control group
The participants received r-tPA thrombolytic therapy after diagnosed ischemic stroke. In addition, all participants receive a standard clinical therapy.
结局指标
主要结局
infarction volume in brain between two groups
时间窗: measured during 72 h
assess by MRI-DWI and ADC
次要结局
- The score of Modified Rankin scale score(measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days)
- proportional of Modified Rankin scale scored 0-1(measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days)
- recurrence of stroke and TIA(changes from baseline(before RIPC) to 90±7 days)
- The score of National Institute of Health stroke scale score(measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days)
- The score of Barthel Index(BI)(measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days)
- The number of patients with erythema,and/or skin lesions related to RIC(during 90 days)
- level of MMP-9(measured at baseline(before RIPC,after rtPA) and 7 days)
- death and any other adverse events(changes from baseline(before RIPC) to 90±7 days)
- the score of Hamilton Rating Scale for Depression（HAMAD）(change from baseline(before rtPA) to 90 days)
- any ICH(changes from baseline(before RIPC) to 90±7 days)
- Distal radial pulses(during 90 days)
- Visual inspection for local edema(during 90 days)
- level of IL-6(measured at baseline(before RIPC,after rtPA) and 7 days)
- level of HS-CRP(measured at baseline(before RIPC,after rtPA) and 7 days)
- The level of vascular endothelial growth factor(measured at baseline(before RIPC,after rtPA) and 7 days)
- Palpation for tenderness(during 90 days)
- The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure(during 90 days)
- the score of Numeric Rating Scale (NRS)(during 90 days)
研究者
Ji Xunming,MD,PhD
professor
Capital Medical University