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 (56) 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 Changda Hospital
RECRUITING
Anshan
Aerospace Central Hospital
RECRUITING
Beijing
Beijing Chao-Yang Hospital
RECRUITING
Beijing
Beijing Daxing District People's Hospital
RECRUITING
Beijing
Beijing Fangshan District First Hospital
RECRUITING
Beijing
Beijing Fengtai You'anmen Hospital
RECRUITING
Beijing
Beijing Luhe Hospital affiliated to Capital Medical University
RECRUITING
Beijing
Beijing Red Cross Emergency Medical Center
RECRUITING
Beijing
Xuanwu Hospital, Capital Medical University
RECRUITING
Beijing
Cangzhou Central Hospital
RECRUITING
Cangzhou
the First People's Hospital of Changde
RECRUITING
Changde
The Third Xiangya Hospital of Central South University
RECRUITING
Changsha
the First People's Hospital of Chenzhou
NOT_YET_RECRUITING
Chenzhou
Chongqing University Fuling Hospital
NOT_YET_RECRUITING
Chongqing
Dalian Central Hospital
NOT_YET_RECRUITING
Dalian
The First Affiliated Hospital of Dalian Medical University
RECRUITING
Dalian
Shengli Oilfield Central Hospital
RECRUITING
Dongying
Fujian Provincial Hospital
NOT_YET_RECRUITING
Fuzhou
Xunxian People's Hospital
RECRUITING
Hebi
Inner Mongolia Autonomous Region People's Hospital
NOT_YET_RECRUITING
Hohhot
Huanggang Central hospital
RECRUITING
Huanggang
Huangshi central hospital
RECRUITING
Huangshi
The Hongda Hospital of Jiamusi University
RECRUITING
Jiamusi
Jiaozuo Coal Industry Group Co., Ltd. Central Hospital
RECRUITING
Jiaozuo
Jinan Third People's Hospital
RECRUITING
Jinan
Jingmen Central hospital
RECRUITING
Jingmen
Jingmen People's Hospital
RECRUITING
Jingmen
Liaocheng People's Hospital
RECRUITING
Liaocheng
Liaocheng Third People's Hospital
RECRUITING
Liaocheng
The People's Hospital of Gaotang
RECRUITING
Liaocheng
Feixian People's Hospital
SUSPENDED
Linyi
Luoyang Yanshi People's Hospital
RECRUITING
Luoyang
Mianyang third people's hospital
RECRUITING
Mianyang
The Second Nanning People's Hospital
RECRUITING
Nanning
Nanyang Central Hospital
RECRUITING
Nanyang
Shenzhen Second People's Hospital
NOT_YET_RECRUITING
Shenzhen
South China Hospital Affiliated to Shenzhen University
RECRUITING
Shenzhen
Army Medical University Noncommissioned Officer School Affiliated Hospital
RECRUITING
Shijiazhuang
Hebei General Hospital
NOT_YET_RECRUITING
Shijiazhuang
Suzhou Municipal Hospital of Anhui Province
RECRUITING
Suzhou
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
The Fourth Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Taihe County People's Hospital
RECRUITING
Taihe Chengguanzhen
First People's Hospital of Tianmen
SUSPENDED
Tianmen
Tongling People's Hospital
RECRUITING
Tongling
The Second Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
The Third People's Hospital of Hubei Province
NOT_YET_RECRUITING
Wuhan
Zhongnan Hospital of Wuhan University
RECRUITING
Wuhan
The Central Hospital of Xiangtan
NOT_YET_RECRUITING
Xiangtan
Ya 'an People's Hospital
RECRUITING
Ya'an
Yeda Hospital
RECRUITING
Yantai
Yichang Central People's Hospital
RECRUITING
Yichang
Yueqing People's Hospital
RECRUITING
Yueqing
Zhangzhou Municipal Hospital of Fujian Province
RECRUITING
Zhangzhou
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.
Related Therapeutic Areas
Sponsors
Leads: Capital Medical University

This content was sourced from clinicaltrials.gov

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