NeuroPRotective Effect of remOte Ischemic condiTioning in Ischemic strokE Treated With meChanical Thrombectomy (PROTECT-I Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Final volume of cerebral infarction measured by Magnetic Resonance Imaging (MRI) at Day 1 after thrombectomy
研究概览
简要总结
The benefit of mechanical thrombectomy in the treatment of ischemic stroke has been demonstrated in several multicenter randomized trials. However, it leads to a sudden reperfusion of the brain parenchyma associated to an extension of the infarct volume. Evidence has indicated that remote ischemic conditioning (RIC) reduces final infarct size in animal stroke models. The main objective of the present study is to determine whether remote ischemic conditioning can limit the final infarct volume after recanalization of the occluded cerebral artery.
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
- Double (Participant, 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 at least 18 years old,
- •Carotid ischemic stroke related to a full occlusion of the middle cerebral artery (occlusion of middle 1 (M1) and/or proximal middle 2 (M2) identified as candidate for endovascular intervention according to local criteria,
- •Brain Magnetic Resonance Imaging (MRI) performed within 6 hours from symptoms onset,
- •Acute stroke MRI including at least diffusion weighted imaging (DWI), fluid attenuated inversion recovery (FLAIR), intracranial vessel imaging with Magnetic Resonance Angiography (MRA) and perfusion weighted imaging (PWI),
- •Modified Rankin Score (mRS) score less than or equal to 1 before ischemic stroke,
- •Obtaining a written informed consent of the patient or a next of kin, or emergency inclusion process.
- •Non inclusion Criteria:
- •Previous ischemic stroke or transient ischemic attack (TIA) in the previous 3 months,
- •Contraindications to iodinated contrast agents,
- •Sickle cell disease known (risk of vaso-occlusive crisis),
- •Life expectancy less than 90 days,
- •Pregnant or women of childbearing age who were not using contraception (oral diagnosis),
- •Patient without health coverage,
- •Patient under legal protection.
- •Any contraindication to Magnetic Resonance Imaging (MRI) (example cardiac pacemaker),
- •Intracranial bleeding,
- •Intracranial expansive process.
排除标准
- •Recanalization of M1 or proximal M2 segment at the time of thrombectomy
研究组 & 干预措施
Remote Ischemic Conditioning (RIC) positive
Patients with remote ischemic conditioning
干预措施: Remote ischemic conditioning (Device)
Control group
The control group will receive a sham procedure (same procedure than Remote Ischemic Conditioning (RIC) with brachial cuff inflation to 30 millimeters (mm) of mercury (Hg) during 40 minutes).
干预措施: Patients with a sham procedure of remote ischemic conditioning (Device)
结局指标
主要结局
Final volume of cerebral infarction measured by Magnetic Resonance Imaging (MRI) at Day 1 after thrombectomy
时间窗: Day 1 after thrombectomy
Measurement of the final volume of cerebral infarction on Fluid Attenuated Inversion Recovery (FLAIR) sequence by a blinding imaging reading committee.
次要结局
- Arterial reperfusion measured at Day 1 by Magnetic Resonance Imaging (MRI).(Day 1)
- Complications related to the endovascular procedure(Day 1)
- Change in growth of the supposed irreversible lesion measured by Magnetic Resonance Imaging (MRI) from admission to day 1.(Magnetic Resonance Imaging (MRI) will be performed at inclusion (Day 0) and on day 1.)
- Arterial reperfusion measured by the Thrombolysis in Cerebral Infarction (TICI) score at the end of the thrombectomy procedure.(Day 1 of thrombectomy)
- Impact on collateral circulation assessed by the Higashida score.(Day 1)
- Incidence of hemorrhagic transformation at day 1 measured by routine Magnetic Resonance Imaging (MRI)(Day 1)
- Responder analysis to thrombectomy relating Modified Rankin score (mRS) 90 days after stroke to baseline National Institutes of Health Stroke Scale (NIHSS) score.(Day 90)
- Change in Neurological prognosis(1/ National Institutes of Health Stroke Scale (NIHSS) score will be evaluated at day 7; 2/ Modified Rankin Score (mRS) will be evaluated at day 90 and 3/ Incidence of early neurological worsening will be evaluated at inclusion and up to day 1.)