Endovascular Treatment Combined With Remote Ischemic Postconditioning in Patients With Acute Ischemic Stroke Improves the Prognosis，a Multicenter, Randomized, Prospective Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Modified Rankin scale (mRS)
研究概览
简要总结
Endovascular treatment（ET）is an effective therapy for acute ischemic stroke(AIS) with great vessel obstruction. However, acute complications such as high postoperative perfusion injury, hemorrhagic transformation and restenosis resulted in functional independence in only about 50% of patients 90 days after interventional surgery. Therefore, it is very important to protect the neurologic function after emergency endovascular treatment. The investigators' previous studies have shown that combined with intravenous thrombolytic therapy and remote postconditioning（RIPC）can significantly improve the neurological impairment and short-term and long-term prognosis in patients with acute stroke. In this multicenter, randomized controlled trial, the investigators assumed patients with acute ischemic stroke who had successfully revascularization after ET might benefit from RIPC as well. Patients in the RIPC group had five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm after ET. The primary endpoint measure was the proportion of patients with a favorable recovery of nerve function deficient assessed by Modified Rankin Scale （mRS≤2） 90 days after surgery. Secondary endpoints included the following: (1) Symptom endpoints: Neurological intelligence and function scores, postoperative hemorrhagic transformation rate, etc. (2) Blood index test: postoperative inflammatory factors, neuron-specific enolase (NSE) and other indicators. (3) Imaging endpoints: MRI-FLAIR , TCD, etc.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute ischemic stroke（AIS） patients with large vessel occlusion (internal carotid artery system and vertebral basilar artery system) within 24 hours after onset, endovascular treatment (mechanical thrombotomy, intra-arterial thrombolysis, balloon dilatation or stent angioplastyand) successful opening were performed, and the definition of successful opening was defined by Modified Thrombolysis standard [Modified Thrombolysis in Cerebral infarction, mTICI]≥ 2B，The standards of endovascular interventional treatment are in line with the indications and contraindications formulated in the Chinese Guidelines for the Early Treatment of Acute Ischemic Stroke 2018；
- •Modified Rankin scale score (mRS) ≤1 before onset:
- •The Alberta Stroke Program Early CT score (ASPECTS)≥6 on admission;
- •National Institute of Health Stroke Scale (NIHSS) score ≥6 on admission;
- •Provision of written informed consent.
排除标准
- •CT or MRI scan showed significant midline deviation and the mass effect;
- •Glasgow(GCS) score ≤8 on admission;
- •failure to accomplish 3-months and 6-months follow up;
- •Severe cardiac, liver, or kidney disease, malignancy, severe coagulation dysfunction, severe anemia and systemic organ dysfunction;
- •Pregnant or nursing women, or patients with moderate to severe mental disorders or dementia;
- •Severe soft tissue injuries, fractures, thrombosis and other known peripheral vascular lesions of the upper limbs，active visceral hemorrhage, acute stage of fundus hemorrhage, cerebral aneurysm or cerebral arteriovenous malformation, and other unsuitable for bilateral upper arm compression.
研究组 & 干预措施
RIPC
Patients in the RIPC group not only receive foundational treatment but also have five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm using a RIPC device (IPC-906X; Beijing Renqiao Institute of Neuroscience, Beijing, China) after endovascular treatment while in-hospital.
干预措施: RIPC device (IPC-906X) (Device)
RIPC
Patients in the RIPC group not only receive foundational treatment but also have five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm using a RIPC device (IPC-906X; Beijing Renqiao Institute of Neuroscience, Beijing, China) after endovascular treatment while in-hospital.
干预措施: foundational treatment (Drug)
foundational treatment group (FT)
Patients in the FT group only receive foundational treatment, including free radical elimination in the acute stage, blood pressure and blood glucose stabilization, and antiplatelet (aspirin or/and clopidogrel,100-300mg/d) and lipid-lowering (atorvastatin 20-60mg/d,rosuvastatin 10-20mg/d) drugs, during the study period without remote ischemic postconditioning after endovascular treatment.
干预措施: foundational treatment (Drug)
结局指标
主要结局
Modified Rankin scale (mRS)
时间窗: 7days, 90 days and 180 days after the surgery and at discharge
The percentage of patients with a favorable outcome from baseline at 90 days and 180 days postoperatively, defined as a score of 0 or 2 on the modified Rankin scale (mRS)（Notes:mRS score from 0-6, higher scores mean worse outcome）
次要结局
- The change of NIHSS score(7days, 90 days and 180 days after the surgery and at discharge)
- The change of inflammatory indicators(before ET, 24 hours and 7 days after the surgery)
- Postoperative hemorrhagic transformation(72 hours after ET and hospitalization)
- The change of blood flow velocity(the changs from 24 hours after ET to 7 days after the surgery)
- The change of Montreal Cognitive Assessment (MoCA) score(7days, 90 days and 180 days after the surgery and at discharge)
- The change of hemoglobin and Blood viscosity(up to 7 days after the surgery)
- The change of MRI FLAIR Fazekas score(the changs from within 7 days to 90 days after the surgery)
- heart rate(up to 7days)
- Vascular resistance(the changs from 24 hours after ET to 7 days after the surgery)
- recurrence rate of cerebrovascular disease(up to 90 days and 180 days)
- mortality rate(up to 90 days and 180 days)
- The change of Barthel Index(7days, 90 days and 180 days after the surgery and at discharge)
- blood pressure(up to 7days)
- The change of MMSE score(7days, 90 days and 180 days after the surgery and at discharge)
- The change of angiogenic factors(before ET, 24 hours and 7 days after the surgery)