Remote Ischemic Conditioning for Acute Ischemic Stroke Treated With Mechanical Thrombectomy(RECAST-MT)

NCT ID: NCT06559241

Last Updated: 2025-12-10

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

2105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-23

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Ischemic Stroke Anterior Circulation Brain Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type OTHER

Endovascular thrombectomy

Intervention Type PROCEDURE

Endovascular thrombectomy procedures are performed according to the guidelines to recanalize the occluded large vessel safely.

Best medical management

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

14-day remote ischemic conditioning

Intervention Type DEVICE

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

Intervention Type PROCEDURE

Endovascular thrombectomy procedures are performed according to the guidelines to recanalize the occluded large vessel safely.

Best medical management

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

30-day remote ischemic conditioning

Intervention Type DEVICE

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

Intervention Type PROCEDURE

Endovascular thrombectomy procedures are performed according to the guidelines to recanalize the occluded large vessel safely.

Best medical management

Intervention Type DRUG

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Endovascular thrombectomy

Endovascular thrombectomy procedures are performed according to the guidelines to recanalize the occluded large vessel safely.

Intervention Type PROCEDURE

Best medical management

Best medical management is prescribed at the discretion of the treating physicians according to the guidelines.

Intervention Type DRUG

Other Intervention Names

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14-day RIC 30-day RIC EVT

Eligibility Criteria

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Inclusion Criteria

1. Age≥18 years;
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

1. 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);
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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ji Xunming,MD,PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Suzhou Municipal Hospital of Anhui Province

Suzhou, Anhui, China

Site Status RECRUITING

Taihe County People's Hospital

Taihe Chengguanzhen, Anhui, China

Site Status RECRUITING

Tongling People's Hospital

Tongling, Anhui, China

Site Status RECRUITING

Beijing Luhe Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Fangshan District First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Fujian Provincial Hospital

Fuzhou, Fujian, China

Site Status NOT_YET_RECRUITING

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, Fujian, China

Site Status RECRUITING

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Site Status NOT_YET_RECRUITING

South China Hospital Affiliated to Shenzhen University

Shenzhen, Guangdong, China

Site Status RECRUITING

The Second Nanning People's Hospital

Nanning, Guangxi, China

Site Status RECRUITING

Cangzhou Central Hospital

Cangzhou, Hebei, China

Site Status RECRUITING

Army Medical University Noncommissioned Officer School Affiliated Hospital

Shijiazhuang, Hebei, China

Site Status RECRUITING

Hebei General Hospital

Shijiazhuang, Hebei, China

Site Status NOT_YET_RECRUITING

The Hongda Hospital of Jiamusi University

Jiamusi, Heilongjiang, China

Site Status RECRUITING

Xunxian People's Hospital

Hebi, Henan, China

Site Status RECRUITING

Jiaozuo Coal Industry Group Co., Ltd. Central Hospital

Jiaozuo, Henan, China

Site Status RECRUITING

Luoyang Yanshi People's Hospital

Luoyang, Henan, China

Site Status RECRUITING

Nanyang Central Hospital

Nanyang, Henan, China

Site Status RECRUITING

Henan Province People's Hospital

Zhengzhou, Henan, China

Site Status NOT_YET_RECRUITING

Xihua county people's hospital

Zhoukou, Henan, China

Site Status RECRUITING

Huanggang Central hospital

Huanggang, Hubei, China

Site Status RECRUITING

Huangshi central hospital

Huangshi, Hubei, China

Site Status RECRUITING

Jingmen Central hospital

Jingmen, Hubei, China

Site Status RECRUITING

Jingmen People's Hospital

Jingmen, Hubei, China

Site Status RECRUITING

First People's Hospital of Tianmen

Tianmen, Hubei, China

Site Status SUSPENDED

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

The Third People's Hospital of Hubei Province

Wuhan, Hubei, China

Site Status NOT_YET_RECRUITING

Yichang Central People's Hospital

Yichang, Hubei, China

Site Status RECRUITING

the First People's Hospital of Changde

Changde, Hunan, China

Site Status RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

the First People's Hospital of Chenzhou

Chenzhou, Hunan, China

Site Status NOT_YET_RECRUITING

The Central Hospital of Xiangtan

Xiangtan, Hunan, China

Site Status NOT_YET_RECRUITING

Inner Mongolia Autonomous Region People's Hospital

Hohhot, Inner Mongolia, China

Site Status NOT_YET_RECRUITING

The Fourth Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status RECRUITING

Anshan Changda Hospital

Anshan, Liaoning, China

Site Status RECRUITING

Dalian Central Hospital

Dalian, Liaoning, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status RECRUITING

Shengli Oilfield Central Hospital

Dongying, Shandong, China

Site Status RECRUITING

Jinan Third People's Hospital

Jinan, Shandong, China

Site Status RECRUITING

Liaocheng People's Hospital

Liaocheng, Shandong, China

Site Status RECRUITING

Liaocheng Third People's Hospital

Liaocheng, Shandong, China

Site Status RECRUITING

The People's Hospital of Gaotang

Liaocheng, Shandong, China

Site Status RECRUITING

Feixian People's Hospital

Linyi, Shandong, China

Site Status SUSPENDED

Yeda Hospital

Yantai, Shandong, China

Site Status RECRUITING

Mianyang third people's hospital

Mianyang, Sichuan, China

Site Status RECRUITING

Ya 'an People's Hospital

Ya'an, Sichuan, China

Site Status RECRUITING

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status RECRUITING

Yueqing People's Hospital

Yueqing, Zhejiang, China

Site Status RECRUITING

Beijing Chao-Yang Hospital

Beijing, , China

Site Status RECRUITING

Aerospace Central Hospital

Beijing, , China

Site Status RECRUITING

Xuanwu Hospital, Capital Medical University

Beijing, , China

Site Status RECRUITING

Beijing Fengtai You'anmen Hospital

Beijing, , China

Site Status RECRUITING

Beijing Red Cross Emergency Medical Center

Beijing, , China

Site Status RECRUITING

Beijing Daxing District People's Hospital

Beijing, , China

Site Status RECRUITING

Chongqing University Fuling Hospital

Chongqing, , China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Xunming Ji, MD, PhD

Role: CONTACT

010-8319-9439

Sijie Li, MD

Role: CONTACT

+8613581610258

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

8617762473010

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

Xunming Ji, MD, PhD

Role: primary

010-83199430

Sijie Li, MD

Role: backup

86-13581610258

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.

Reference Type RESULT
PMID: 28174194 (View on PubMed)

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.

Reference Type RESULT
PMID: 32166195 (View on PubMed)

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.

Reference Type RESULT
PMID: 33028663 (View on PubMed)

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.

Reference Type DERIVED
PMID: 41290408 (View on PubMed)

Other Identifiers

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RECAST-MT

Identifier Type: -

Identifier Source: org_study_id

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