Remote Ischemic Conditioning for Acute Ischemic Stroke Treated With Mechanical Thrombectomy（RECAST-MT）
RECAST-MT
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
1 other identifier
interventional
2,105
1 country
56
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2024
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2024
CompletedFirst Posted
Study publicly available on registry
August 19, 2024
CompletedStudy Start
First participant enrolled
September 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
December 10, 2025
December 1, 2025
2.1 years
August 4, 2024
December 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 90 days.
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
90 days after stroke.
Secondary Outcomes (13)
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.
The ordinal distribution of mRS scores at 90 days.
90 days after stroke.
The proportion of patients with early neurological improvement 24 hours after endovascular procedures.
24 hours after endovascular procedures.
Changes in NIHSS score from baseline to day 14 or at discharge (whichever comes earlier).
14 days or at discharge (whichever comes first)
Score of EQ-5D-5L at 90 days.
90 days after stroke.
- +8 more secondary outcomes
Study Arms (3)
Control group
OTHERPatients in the control group will receive endovascular thrombectomy and the best medical management according to the guidelines.
14-day treatment group
EXPERIMENTALPatients 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.
30-day treatment group
EXPERIMENTALPatients 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.
Interventions
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.
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 procedures are performed according to the guidelines to recanalize the occluded large vessel safely.
Best medical management is prescribed at the discretion of the treating physicians according to the guidelines.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
Suzhou Municipal Hospital of Anhui Province
Suzhou, Anhui, 234000, China
Taihe County People's Hospital
Taihe Chengguanzhen, Anhui, 236600, China
Tongling People's Hospital
Tongling, Anhui, China
Beijing Luhe Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 100000, China
Beijing Fangshan District First Hospital
Beijing, Beijing Municipality, 100010, China
Fujian Provincial Hospital
Fuzhou, Fujian, 350028, China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, 363000, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518000, China
South China Hospital Affiliated to Shenzhen University
Shenzhen, Guangdong, 518000, China
The Second Nanning People's Hospital
Nanning, Guangxi, 530000, China
Cangzhou Central Hospital
Cangzhou, Hebei, 061000, China
Army Medical University Noncommissioned Officer School Affiliated Hospital
Shijiazhuang, Hebei, 050047, China
Hebei General Hospital
Shijiazhuang, Hebei, 455001, China
The Hongda Hospital of Jiamusi University
Jiamusi, Heilongjiang, 154000, China
Xunxian People's Hospital
Hebi, Henan, 456250, China
Jiaozuo Coal Industry Group Co., Ltd. Central Hospital
Jiaozuo, Henan, 454000, China
Luoyang Yanshi People's Hospital
Luoyang, Henan, 471000, China
Nanyang Central Hospital
Nanyang, Henan, 473000, China
Henan Province People's Hospital
Zhengzhou, Henan, 450000, China
Xihua county people's hospital
Zhoukou, Henan, 466600, China
Huanggang Central hospital
Huanggang, Hubei, 438000, China
Huangshi central hospital
Huangshi, Hubei, 435000, China
Jingmen Central hospital
Jingmen, Hubei, 448000, China
Jingmen People's Hospital
Jingmen, Hubei, 448000, China
First People's Hospital of Tianmen
Tianmen, Hubei, 430000, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000, China
The Third People's Hospital of Hubei Province
Wuhan, Hubei, 430033, China
Yichang Central People's Hospital
Yichang, Hubei, 443000, China
the First People's Hospital of Changde
Changde, Hunan, 415000, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410000, China
the First People's Hospital of Chenzhou
Chenzhou, Hunan, 423000, China
The Central Hospital of Xiangtan
Xiangtan, Hunan, 411100, China
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, 010000, China
The Fourth Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Anshan Changda Hospital
Anshan, Liaoning, Anshan, China
Dalian Central Hospital
Dalian, Liaoning, 116000, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116000, China
Shengli Oilfield Central Hospital
Dongying, Shandong, 257000, China
Jinan Third People's Hospital
Jinan, Shandong, 250000, China
Liaocheng People's Hospital
Liaocheng, Shandong, 252000, China
Liaocheng Third People's Hospital
Liaocheng, Shandong, 252000, China
The People's Hospital of Gaotang
Liaocheng, Shandong, 252800, China
Feixian People's Hospital
Linyi, Shandong, 273400, China
Yeda Hospital
Yantai, Shandong, China
Mianyang third people's hospital
Mianyang, Sichuan, 621000, China
Ya 'an People's Hospital
Ya'an, Sichuan, 625000, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Yueqing People's Hospital
Yueqing, Zhejiang, 325600, China
Beijing Chao-Yang Hospital
Beijing, 100020, China
Aerospace Central Hospital
Beijing, 100049, China
Xuanwu Hospital, Capital Medical University
Beijing, 100053, China
Beijing Fengtai You'anmen Hospital
Beijing, 100071, China
Beijing Red Cross Emergency Medical Center
Beijing, 100085, China
Beijing Daxing District People's Hospital
Beijing, 102600, China
Chongqing University Fuling Hospital
Chongqing, 408000, China
Related Publications (4)
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.
PMID: 28174194RESULTZhao 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.
PMID: 32166195RESULTAn 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.
PMID: 33028663RESULTWang 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.
PMID: 41290408DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 4, 2024
First Posted
August 19, 2024
Study Start
September 23, 2024
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
February 1, 2027
Last Updated
December 10, 2025
Record last verified: 2025-12