Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke Treated With Mechanical Thrombectomy (RECAST-MT): A Multicenter, Randomized, Controlled, Open-label, Blinded Endpoint Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,105
- 试验地点
- 56
- 主要终点
- The proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 90 days.
研究概览
简要总结
For patients with acute ischemic stroke caused by large vessel occlusion, endovascular thrombectomy has been demonstrated to be the most effective therapy, as approximately 90% of the occluded vessels can be recanalized. However, less than 50% of patients could achieve functional independence, and over 15% died 90 days after stroke. Although the mismatch of successful recanalization with poor prognosis can be attributed to many factors, the infarct core formed during thrombectomy and reperfusion injury after thrombectomy may be among the most important and effective neuroprotective strategies urgently needed.
Remote ischemic conditioning (RIC) is a noninvasive strategy in which one or more cycles of brief and transient limb ischemia confer protection against prolonged and severe ischemia in distant organs. In the transient focal cerebral ischemia-reperfusion model, the application of remote ischemic conditioning before reperfusion or both before and after reperfusion reduces reperfusion injuries and the final infarct size. Because patients with acute ischemic stroke who are treated with endovascular thrombectomy can achieve a high rate of recanalization after focal ischemia, this patient population is akin to the model of transient focal cerebral ischemia-reperfusion. Furthermore, a pilot study has determined the safety and feasibility of remote ischemic conditioning in patients undergoing endovascular thrombectomy. However, whether remote ischemic conditioning could provide clinical benefits to patients with acute ischemic stroke who are treated with endovascular thrombectomy urgently needs investigations.
This study aims to investigate the safety and efficacy of remote ischemic conditioning in improving functional outcomes of patients with acute ischemic stroke treated with endovascular thrombectomy and explore the effect of treatment duration on the treatment outcome of remote ischemic conditioning.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years；
- •Acute ischemic stroke due to large vessel occlusion in the anterior circulation that is not suitable for intravenous thrombolytic therapy, or has contraindications to intravenous thrombolytic therapy, or treated with intravenous thrombolytic therapy without recanalization;
- •Large vessel occlusion confirmed by computed tomography angiography (CTA) or magnetic resonance angiography (MRA), including the occlusion of the intracranial segment of the internal carotid artery (ICA) and M1 segment of the middle cerebral artery (MCA), is the cause of symptoms, and mechanical thrombectomy is planned within 24 hours from the time last known well;
- •Baseline score of the National Institutes of Health Stroke Scale (NIHSS) ≥ 6 points;
- •Patients or family members signed a written informed consent form.
排除标准
- •Imaging examination revealed the presence of multiple vascular supply areas of cerebral infarction (such as the simultaneous presence of infarction in both anterior and posterior circulation);
- •Absence of femoral artery pulsation, extremely difficult intravascular access, or extremely tortuous large vessels, which are expected to result in the inability to undergo timely endovascular treatment;
- •Difficult-to-control hypertension: continuous monitoring upon admission shows systolic blood pressure ≥180mmHg, or diastolic blood pressure ≥100mmHg;
- •Coma or lethargy patients (consciousness level score ≥2 in NIHSS);
- •Unable to obtain an accurate baseline NIHSS score;
- •Pre-stroke modified Rankin Scale (mRS) score >1;
- •Baseline ASPECTS score ≤5;
- •Presence of bleeding tendency, deficiency of coagulation factors, or oral anticoagulant therapy with INR > 3.0;
- •Baseline blood glucose <2.7mmol/L or >22.2mmol/L;
- •Baseline platelet count < 30*10^9/L;
- •Severe known renal impairment defined as requiring dialysis (hemodialysis or peritoneal dialysis), or if known creatinine clearance rate <30mL/min;
- •Cranial CT or MRI shows intracranial hemorrhage;
- •Cranial CT or MRI shows midline deviation and significant occupying effect;
- •Clinical history, previous imaging examinations, or clinical judgment suggesting intracranial tumors, arteriovenous malformations, or intracranial arterial dissection;
- •History of head injury in the past 3 months;
- •History of life-threatening allergy to contrast agents, nickel, titanium metal, or their alloys;
- •Pregnancy, if women of childbearing age have a positive urinary or serum β-human chorionic gonadotropin (β-hCG) test or are breastfeeding；
- •The life expectancy of patients is less than 6 months, and they cannot be evaluated within 3 months;
- •Limb deformity, soft tissue injury, or other conditions that affect the implementation of distant ischemia adaptation therapy;
- •Participating in other ongoing clinical trials;
- •Other conditions that the investigators believe are not suitable for participation in this study.
研究组 & 干预措施
Control group
Patients in the control group will receive endovascular thrombectomy and the best medical management according to the guidelines.
干预措施: Endovascular thrombectomy (Procedure)
Control group
Patients in the control group will receive endovascular thrombectomy and the best medical management according to the guidelines.
干预措施: Best medical management (Drug)
14-day treatment group
Patients in the 14-day treatment group will receive endovascular thrombectomy and the best medical management according to the guidelines. In addition, this group will receive remote ischemic conditioning once pre-thrombectomy and twice daily for 14 days post-thrombectomy.
干预措施: 14-day remote ischemic conditioning (Device)
14-day treatment group
Patients in the 14-day treatment group will receive endovascular thrombectomy and the best medical management according to the guidelines. In addition, this group will receive remote ischemic conditioning once pre-thrombectomy and twice daily for 14 days post-thrombectomy.
干预措施: Endovascular thrombectomy (Procedure)
14-day treatment group
Patients in the 14-day treatment group will receive endovascular thrombectomy and the best medical management according to the guidelines. In addition, this group will receive remote ischemic conditioning once pre-thrombectomy and twice daily for 14 days post-thrombectomy.
干预措施: Best medical management (Drug)
30-day treatment group
Patients in the 30-day treatment group will receive endovascular thrombectomy and the best medical management according to the guidelines. In addition, this group will receive remote ischemic conditioning once pre-thrombectomy and twice daily for 30 days post-thrombectomy.
干预措施: 30-day remote ischemic conditioning (Device)
30-day treatment group
Patients in the 30-day treatment group will receive endovascular thrombectomy and the best medical management according to the guidelines. In addition, this group will receive remote ischemic conditioning once pre-thrombectomy and twice daily for 30 days post-thrombectomy.
干预措施: Endovascular thrombectomy (Procedure)
30-day treatment group
Patients in the 30-day treatment group will receive endovascular thrombectomy and the best medical management according to the guidelines. In addition, this group will receive remote ischemic conditioning once pre-thrombectomy and twice daily for 30 days post-thrombectomy.
干预措施: Best medical management (Drug)
结局指标
主要结局
The proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 90 days.
时间窗: 90 days after stroke.
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
次要结局
- Two dichotomous mRS scores at 90 days (0-1 vs 2-6, 0-3 vs 4-6, 0-4 vs 5-6, 0-5 vs 6).(90 days after stroke.)
- Changes in NIHSS score from baseline to day 14 or at discharge (whichever comes earlier).(14 days or at discharge (whichever comes first))
- The change of infarct volume.(72 hours after endovascular procedures.)
- The ordinal distribution of mRS scores at 90 days.(90 days after stroke.)
- Score of EQ-5D-5L at 90 days.(90 days after stroke.)
- Incidence of malignant infarction(0-90 days)
- The proportion of patients with early neurological improvement 24 hours after endovascular procedures.(24 hours after endovascular procedures.)
- Cerebral infarct volume.(72 hours after endovascular procedures.)
- All cause of death.(0-90 days)
- Incidence of Adverse Events/Serious Adverse Events(0-90 days)
- Incidence of intracranial hemorrhage.(Within 14 days after endovascular procedures.)
- Incidence of Symptomatic Intracranial Hemorrhage(Within 14 days after endovascular procedures.)
- Incidence of neurological deterioration within 14 days.(Within 14 days after endovascular procedures.)
研究者
Ji Xunming,MD,PhD
Professor
Capital Medical University