Remote Ischemic Conditioning for Acute Ischemic Stroke Treated With Mechanical Thrombectomy(RECAST-MT)
NCT ID: NCT06559241
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
2105 participants
INTERVENTIONAL
2024-09-23
2027-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group
Patients in the control group will receive endovascular thrombectomy and the best medical management according to the guidelines.
Endovascular thrombectomy
Endovascular thrombectomy procedures are performed according to the guidelines to recanalize the occluded large vessel safely.
Best medical management
Best medical management is prescribed at the discretion of the treating physicians according to the guidelines.
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.
14-day remote ischemic conditioning
RIC is a noninvasive therapy performed by an electric auto-control device with a cuff placed on the upper arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of the cuff on the upper arm. The procedure will be performed once before endovascular thrombectomy and twice daily for 14 days post-thrombectomy.
Endovascular thrombectomy
Endovascular thrombectomy procedures are performed according to the guidelines to recanalize the occluded large vessel safely.
Best medical management
Best medical management is prescribed at the discretion of the treating physicians according to the guidelines.
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.
30-day remote ischemic conditioning
RIC is a noninvasive therapy performed by an electric auto-control device with a cuff placed on the upper arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of the cuff on the upper arm. The procedure will be performed once before endovascular thrombectomy and twice daily for 30 days post-thrombectomy.
Endovascular thrombectomy
Endovascular thrombectomy procedures are performed according to the guidelines to recanalize the occluded large vessel safely.
Best medical management
Best medical management is prescribed at the discretion of the treating physicians according to the guidelines.
Interventions
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14-day remote ischemic conditioning
RIC is a noninvasive therapy performed by an electric auto-control device with a cuff placed on the upper arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of the cuff on the upper arm. The procedure will be performed once before endovascular thrombectomy and twice daily for 14 days post-thrombectomy.
30-day remote ischemic conditioning
RIC is a noninvasive therapy performed by an electric auto-control device with a cuff placed on the upper arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of the cuff on the upper arm. The procedure will be performed once before endovascular thrombectomy and twice daily for 30 days post-thrombectomy.
Endovascular thrombectomy
Endovascular thrombectomy procedures are performed according to the guidelines to recanalize the occluded large vessel safely.
Best medical management
Best medical management is prescribed at the discretion of the treating physicians according to the guidelines.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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;
3. 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;
4. Baseline score of the National Institutes of Health Stroke Scale (NIHSS) ≥ 6 points;
5. Patients or family members signed a written informed consent form.
Exclusion Criteria
2. 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;
3. Difficult-to-control hypertension: continuous monitoring upon admission shows systolic blood pressure ≥180mmHg, or diastolic blood pressure ≥100mmHg;
4. Coma or lethargy patients (consciousness level score ≥2 in NIHSS);
5. Unable to obtain an accurate baseline NIHSS score;
6. Pre-stroke modified Rankin Scale (mRS) score \>1;
7. Baseline ASPECTS score ≤5;
8. Presence of bleeding tendency, deficiency of coagulation factors, or oral anticoagulant therapy with INR \> 3.0;
9. Baseline blood glucose \<2.7mmol/L or \>22.2mmol/L;
10. Baseline platelet count \< 30\*10\^9/L;
11. Severe known renal impairment defined as requiring dialysis (hemodialysis or peritoneal dialysis), or if known creatinine clearance rate \<30mL/min;
12. Cranial CT or MRI shows intracranial hemorrhage;
13. Cranial CT or MRI shows midline deviation and significant occupying effect;
14. Clinical history, previous imaging examinations, or clinical judgment suggesting intracranial tumors, arteriovenous malformations, or intracranial arterial dissection;
15. History of head injury in the past 3 months;
16. History of life-threatening allergy to contrast agents, nickel, titanium metal, or their alloys;
17. Pregnancy, if women of childbearing age have a positive urinary or serum β-human chorionic gonadotropin (β-hCG) test or are breastfeeding;
18. The life expectancy of patients is less than 6 months, and they cannot be evaluated within 3 months;
19. Limb deformity, soft tissue injury, or other conditions that affect the implementation of distant ischemia adaptation therapy;
20. Participating in other ongoing clinical trials;
21. Other conditions that the investigators believe are not suitable for participation in this study.
18 Years
ALL
No
Sponsors
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Capital Medical University
OTHER
Responsible Party
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Ji Xunming,MD,PhD
Professor
Locations
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Suzhou Municipal Hospital of Anhui Province
Suzhou, Anhui, China
Taihe County People's Hospital
Taihe Chengguanzhen, Anhui, China
Tongling People's Hospital
Tongling, Anhui, China
Beijing Luhe Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Beijing Fangshan District First Hospital
Beijing, Beijing Municipality, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
South China Hospital Affiliated to Shenzhen University
Shenzhen, Guangdong, China
The Second Nanning People's Hospital
Nanning, Guangxi, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
Army Medical University Noncommissioned Officer School Affiliated Hospital
Shijiazhuang, Hebei, China
Hebei General Hospital
Shijiazhuang, Hebei, China
The Hongda Hospital of Jiamusi University
Jiamusi, Heilongjiang, China
Xunxian People's Hospital
Hebi, Henan, China
Jiaozuo Coal Industry Group Co., Ltd. Central Hospital
Jiaozuo, Henan, China
Luoyang Yanshi People's Hospital
Luoyang, Henan, China
Nanyang Central Hospital
Nanyang, Henan, China
Henan Province People's Hospital
Zhengzhou, Henan, China
Xihua county people's hospital
Zhoukou, Henan, China
Huanggang Central hospital
Huanggang, Hubei, China
Huangshi central hospital
Huangshi, Hubei, China
Jingmen Central hospital
Jingmen, Hubei, China
Jingmen People's Hospital
Jingmen, Hubei, China
First People's Hospital of Tianmen
Tianmen, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
The Third People's Hospital of Hubei Province
Wuhan, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
the First People's Hospital of Changde
Changde, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
the First People's Hospital of Chenzhou
Chenzhou, Hunan, China
The Central Hospital of Xiangtan
Xiangtan, Hunan, China
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, China
The Fourth Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Anshan Changda Hospital
Anshan, Liaoning, China
Dalian Central Hospital
Dalian, Liaoning, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Shengli Oilfield Central Hospital
Dongying, Shandong, China
Jinan Third People's Hospital
Jinan, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Liaocheng Third People's Hospital
Liaocheng, Shandong, China
The People's Hospital of Gaotang
Liaocheng, Shandong, China
Feixian People's Hospital
Linyi, Shandong, China
Yeda Hospital
Yantai, Shandong, China
Mianyang third people's hospital
Mianyang, Sichuan, China
Ya 'an People's Hospital
Ya'an, Sichuan, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Yueqing People's Hospital
Yueqing, Zhejiang, China
Beijing Chao-Yang Hospital
Beijing, , China
Aerospace Central Hospital
Beijing, , China
Xuanwu Hospital, Capital Medical University
Beijing, , China
Beijing Fengtai You'anmen Hospital
Beijing, , China
Beijing Red Cross Emergency Medical Center
Beijing, , China
Beijing Daxing District People's Hospital
Beijing, , China
Chongqing University Fuling Hospital
Chongqing, , China
Countries
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Central Contacts
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Facility Contacts
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Lei Zhang
Role: primary
Tao Cui
Role: primary
Tao Wang
Role: primary
Xiaokun Geng
Role: primary
Liang Chen
Role: primary
Qiong Cheng
Role: primary
Tingyu Yi
Role: primary
Pengcheng Fu
Role: primary
Shiwei Du
Role: primary
Tong Li
Role: primary
Yongchang Liu
Role: primary
Jin Li
Role: primary
Guodong Xu
Role: primary
Changsi Ai
Role: primary
Beihai Jiang
Role: primary
Qianqian Qiu
Role: primary
Yang Zhou
Role: primary
Changming Wen
Role: primary
Liangfu Zhu
Role: primary
Chaoqun Li
Role: primary
Jiajun Wang
Role: primary
Chensong Deng
Role: primary
Ying Wei
Role: primary
Wei Li
Role: primary
Huagang Li
Role: primary
Yue Wan
Role: primary
Huajun Zhou
Role: primary
Jun Wen
Role: primary
Yi Yuan
Role: primary
Xiaoxi Yao
Role: primary
Guangxiong Yuan
Role: primary
Dong Wang
Role: primary
Qi Fang
Role: primary
Qi Fang
Role: primary
Fan Zhang
Role: primary
Ke Li
Role: primary
Ye Lang
Role: primary
Yan Li
Role: primary
Liyong Zhang
Role: primary
Lei Yang
Role: primary
Huqing Li
Role: primary
Wenjun Qian
Role: primary
Hongxia Yang
Role: primary
Jian Wang
Role: primary
Bo Yin
Role: primary
Saizhen Wu
Role: primary
Yang Wang
Role: primary
Peifu Wang
Role: primary
Jing Wang
Role: primary
Guohui Zhao
Role: primary
Jinglin Yuan
Role: primary
Tao Wang
Role: primary
References
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Zhao W, Meng R, Ma C, Hou B, Jiao L, Zhu F, Wu W, Shi J, Duan Y, Zhang R, Zhang J, Sun Y, Zhang H, Ling F, Wang Y, Feng W, Ding Y, Ovbiagele B, Ji X. Safety and Efficacy of Remote Ischemic Preconditioning in Patients With Severe Carotid Artery Stenosis Before Carotid Artery Stenting: A Proof-of-Concept, Randomized Controlled Trial. Circulation. 2017 Apr 4;135(14):1325-1335. doi: 10.1161/CIRCULATIONAHA.116.024807. Epub 2017 Feb 7.
Zhao W, Wu C, Dornbos D 3rd, Li S, Song H, Wang Y, Ding Y, Ji X. Multiphase adjuvant neuroprotection: A novel paradigm for improving acute ischemic stroke outcomes. Brain Circ. 2020 Feb 18;6(1):11-18. doi: 10.4103/bc.bc_58_19. eCollection 2020 Jan-Mar.
An JQ, Cheng YW, Guo YC, Wei M, Gong MJ, Tang YL, Yuan XY, Song WF, Mu CY, Zhang AF, Saguner AM, Li GL, Luo GG. Safety and efficacy of remote ischemic postconditioning after thrombolysis in patients with stroke. Neurology. 2020 Dec 15;95(24):e3355-e3363. doi: 10.1212/WNL.0000000000010884. Epub 2020 Oct 7.
Wang Y, Huang S, Liu L, Ji X, Zhao W, Li S; RECAST-MT investigators. Safety and Efficacy of Remote Ischaemic Conditioning for Acute Ischaemic Stroke Treated with Mechanical Thrombectomy (RECAST-MT): rationale and design. Stroke Vasc Neurol. 2025 Nov 25:svn-2025-004591. doi: 10.1136/svn-2025-004591. Online ahead of print.
Other Identifiers
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RECAST-MT
Identifier Type: -
Identifier Source: org_study_id
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