A Pilot Study Assessing the Safety and Feasibility of Remote Ischemic Conditioning Paired With Endovascular Treatment for Acute Ischemic Stroke
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of participants with any RIC-related adverse events.
研究概览
简要总结
Currently, early reperfusion is considered as the most effective therapy for the treatment of acute ischemic stroke (AIS). Over the past 20 years, intravenous tissue plasminogen activator (IV tPA) has been demonstrated to be the only effective therapy for AIS. More recently, several large randomized clinical trials have concluded the superiority of endovascular mechanical thrombectomy for AIS. Furthermore, with the development of materials and techniques, the occluded artery can be recanalized with high percentage (60%-90%), and the rate of recanalization is still being improved. A great number of AIS patients are now eligible for revascularization therapy and there should be a good prognosis of AIS after recanalizing the occluded artery using mechanical thrombectomy. However, things are never as simple as wished to be. The rate of patients with functional independence is less than 50% and over 15% patients died at 3 months post thrombectomy. The discrepancy between the functional outcome and recanalization rates encourage researchers to explore strategies that further improving the functional outcome of AIS patients.
Remote ischemic conditioning has been demonstrated to reduce cerebral infarct size in mouse model of focal cerebral ischemia. And clinical researches demonstrated the protective effects of remote ischemic conditioning in AIS patient treated with IV tPA,. However, whether remote ischemic conditioning is safe and effective in protecting patients with large-vessel ischemic stroke and undergoing endovascular treatment is still unknown.
详细描述
In the present study, the investigators will assess the safety and feasibility of remote ischemic condition paired with endovascular treatment for AIS. A single arm of AIS patients treated with endovascular therapy will be recruited, and remote ischemic conditioning will be applied prior to reperfusion therapy and in combination with post reperfusion therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke where patient is ineligible for intravenous thrombolytic treatment or the treatment is contraindicated, or where patient has received intravenous thrombolytic therapy without recanalization;
- •No remarkable pre-stroke functional disability (mRS ≤ 1);
- •Age ≥18 and ≤ 80;
- •Patient treatable within six hours of symptom onset;
- •Informed consent obtained from patient or acceptable patient's surrogate
排除标准
- •Identified hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0;
- •Baseline platelet count < 30*109/L;
- •Baseline blood glucose of < 2.7mmol/L or >22.2mmol/L;
- •Renal insufficiency with creatinine ≥ 265 umol/L;
- •Severe, sustained hypertension (SBP > 185 mmHg or DBP > 110 mmHg);
- •Woman of childbearing potential who is known to be pregnant or lactating;
- •Subject participating in a study involving other drug or device trial study;
- •Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations;
- •Unlikely to be available for 90-day follow-up;
- •Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs;
- •Hypodensity on CT or restricted diffusion amounting to an ASPECTS score of <7 on noncontrast CT;
- •CT or MRI evidence of hemorrhage;
- •Significant mass effect with midline shift on CT or MRI scans;
- •Subjects with artery occlusions in multiple vascular territories;
- •Evidence of intracranial tumor.
研究组 & 干预措施
RIC & ET
Remote ischemic conditioning paired with endovascular treatment. RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on bilateral arms and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 5 times. Endovascular treatment of acute ischemic stroke is performed by experienced neuroradiologist according to the latest guideline from American Heart Association and American Stroke Association. It includes thrombectomy, intra-arterial thrombolysis, thrombus aspiration, stenting and balloon angioplasty.
干预措施: Remote ischemic conditioning (Device)
RIC & ET
Remote ischemic conditioning paired with endovascular treatment. RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on bilateral arms and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 5 times. Endovascular treatment of acute ischemic stroke is performed by experienced neuroradiologist according to the latest guideline from American Heart Association and American Stroke Association. It includes thrombectomy, intra-arterial thrombolysis, thrombus aspiration, stenting and balloon angioplasty.
干预措施: Endovascular treatment (Procedure)
结局指标
主要结局
Number of participants with any RIC-related adverse events.
时间窗: 0-90 days after endovascular treatment.
For all participants, adverse events will be assessed by as assessed by CTCAE v4.0.
次要结局
- Number of subjects completing all the designed RIC procedures.(0-7 days.)
- The severity of global disability at 90 days, as assessed by modified Rankin scale (mRS).(0-90 days.)
- Change in cerebral artery blood flow velocity(0-7 days.)
- Change in vital signs(0-7 days.)
- Change in intracranial pressure(0-7 days.)
- Change in plasma biomarkers(0-7 days.)
- Final cerebral infarct volume.(5-9 days after endovascular treatment.)
- Symptomatic Intracerebral Hemorrhage.(0-90 days.)
- Any adverse event.(0-90 days.)
研究者
Ji Xunming
Clinical Professor, Principal Investigator
Capital Medical University