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
Status: Recruiting
Location: See all (33) locations...
Intervention Type: Device, Procedure, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Anshan zhangda hospital
NOT_YET_RECRUITING
Anshan
Beijing Fangshan District First Hospital
RECRUITING
Beijing
Beijing Luhe Hospital affiliated to Capital Medical University
RECRUITING
Beijing
Xuanwu Hospital, Capital Medical University
RECRUITING
Beijing
the First People'S Hospital of Changde
NOT_YET_RECRUITING
Changde
The Third Xiangya Hospital of Central South University
RECRUITING
Changsha
Xiangya Hospital, Central South University
NOT_YET_RECRUITING
Changsha
Dalian Central Hospital
NOT_YET_RECRUITING
Dalian
The Central Hospital of Shengli Oilfield
NOT_YET_RECRUITING
Dongying
Inner Mongolia Autonomous Region People's Hospital
NOT_YET_RECRUITING
Hohhot
Huanggang Centralhospital
NOT_YET_RECRUITING
Huanggang
Huangshi central hospital
RECRUITING
Huangshi
Jiamusi university hongda hospital
NOT_YET_RECRUITING
Jiamusi
Jiaozuo Coal Industry Group Co., Ltd. Central Hospital
NOT_YET_RECRUITING
Jiaozuo
Jingmen No.1 People's Hospital
NOT_YET_RECRUITING
Jingmen
Jingmen people's hospital
NOT_YET_RECRUITING
Jingmen
Liaocheng Third People's Hospital
RECRUITING
Liaocheng
The People's Hospital of Liaocheng Brain Hospital
RECRUITING
Liaocheng
Feixian county people's hospital
RECRUITING
Linyi
Luoyang Yanshi People's Hospital
NOT_YET_RECRUITING
Luoyang
Mianyang third people's hospital
RECRUITING
Mianyang
Nanning Second People's Hospital
NOT_YET_RECRUITING
Nanning
Shenzhen qianhai shekou free trade zone hospital
NOT_YET_RECRUITING
Shenzhen
South China Hospital Affiliated to Shenzhen University
RECRUITING
Shenzhen
Tianjin huanhu hospital
NOT_YET_RECRUITING
Tianjin
First People's Hospital of Tianmen
RECRUITING
Tianmen
The Second Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
Wuhan University Zhongnan Hospital
RECRUITING
Wuhan
The First People's Hospital of Xiangyang
RECRUITING
Xiangyang
Ya 'an People's Hospital
RECRUITING
Ya'an
Yichang Central People's Hospital
RECRUITING
Yichang
Henan Province People's Hospital
NOT_YET_RECRUITING
Zhengzhou
Xihua county people's hospital
RECRUITING
Zhoukou
Contact Information
Primary
Xunming Ji, MD, PhD
jixm@ccmu.edu.cn
010-8319-9439
Backup
Sijie Li, MD
lisijie@xwh.ccmu.edu.cn
+8613581610258
Time Frame
Start Date:2024-09-23
Estimated Completion Date:2027-02
Participants
Target number of participants:2105
Treatments
Other: Control group
Patients in the control group will receive endovascular thrombectomy and the best medical management according to the guidelines.
Experimental: 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.
Experimental: 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.