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Acute Ischemic StrokePhase 3RECAST-MTNCT06559241

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

A Phase 3 study testing 14-day remote ischemic conditioning, 30-day remote ischemic conditioning and Endovascular thrombectomy in people with Acute Ischemic Stroke and Anterior Circulation Brain Infarction, run by Capital Medical University at 56 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
14-day remote ischemic conditioning, 30-day remote ischemic conditioning and Endovascular thrombectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,105 participants
Where
56 sitesChina
Study dates
23 Sep 2024to Feb 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 21Show fewer
  • 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;
  • History of life-threatening allergy to contrast agents, nickel, titanium metal, or their alloys;
  • Pregnancy, if women of childbearing age have a positive urinary or serum β-human chorionic gonadotropin (β-hCG) test or are breastfeeding；
  • The life expectancy of patients is less than 6 months, and they cannot be evaluated within 3 months;
  • Limb deformity, soft tissue injury, or other conditions that affect the implementation of distant ischemia adaptation therapy;
  • Participating in other ongoing clinical trials;
  • Other conditions that the investigators believe are not suitable for participation in this study.

Trial locations and contacts

56 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xunming Ji, MD, PhD contact

010-8319-9439

jixm@ccmu.edu.cn

Sijie Li, MD contact

+8613581610258

lisijie@xwh.ccmu.edu.cn

56 sites in 1 country

China56 sites, 54 recruiting

  • Anshan Changda Hospital

    Anshan, Liaoning, Anshan

    Fan Zhang

    Recruiting

  • Beijing Luhe Hospital affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100000

    Xiaokun Geng

    Recruiting

  • Beijing Fangshan District First Hospital

    Beijing, Beijing Municipality, 100010

    Liang Chen

    Recruiting

  • Beijing Chao-Yang Hospital

    Beijing, 100020

    Yang Wang

    Recruiting

  • Aerospace Central Hospital

    Beijing, 100049

    Peifu Wang

    Recruiting

  • Xuanwu Hospital, Capital Medical University

    Beijing, 100053

    Xunming Ji, MD, PhD, 010-83199430, jixm@ccmu.edu.cn

    Sijie Li, MD, 86-13581610258, lisijie@xwh.ccmu.edu.cn

    Recruiting

  • Beijing Fengtai You'anmen Hospital

    Beijing, 100071

    Jing Wang

    Recruiting

  • Beijing Red Cross Emergency Medical Center

    Beijing, 100085

    Guohui Zhao

    Recruiting

  • Beijing Daxing District People's Hospital

    Beijing, 102600

    Jinglin Yuan

    Recruiting

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061000

    Yongchang Liu

    Recruiting

  • the First People's Hospital of Changde

    Changde, Hunan, 415000

    Jun Wen

    Recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

    Yi Yuan

    Recruiting

  • the First People's Hospital of Chenzhou

    Chenzhou, Hunan, 423000

    Xiaoxi Yao

    Not yet recruiting

  • Chongqing University Fuling Hospital

    Chongqing, 408000

    Tao Wang

    Not yet recruiting

  • Dalian Central Hospital

    Dalian, Liaoning, 116000

    Not yet recruiting

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116000

    Ke Li

    Recruiting

  • Shengli Oilfield Central Hospital

    Dongying, Shandong, 257000

    Ye Lang

    Recruiting

  • Fujian Provincial Hospital

    Fuzhou, Fujian, 350028

    Qiong Cheng

    Not yet recruiting

  • Xunxian People's Hospital

    Hebi, Henan, 456250

    Beihai Jiang

    Recruiting

  • Inner Mongolia Autonomous Region People's Hospital

    Hohhot, Inner Mongolia, 010000

    Dong Wang

    Not yet recruiting

  • Huanggang Central hospital

    Huanggang, Hubei, 438000

    Jiajun Wang

    Recruiting

  • Huangshi central hospital

    Huangshi, Hubei, 435000

    Chensong Deng

    Recruiting

  • The Hongda Hospital of Jiamusi University

    Jiamusi, Heilongjiang, 154000

    Changsi Ai

    Recruiting

  • Jiaozuo Coal Industry Group Co., Ltd. Central Hospital

    Jiaozuo, Henan, 454000

    Qianqian Qiu

    Recruiting

  • Jinan Third People's Hospital

    Jinan, Shandong, 250000

    Yan Li

    Recruiting

  • Jingmen Central hospital

    Jingmen, Hubei, 448000

    Ying Wei

    Recruiting

  • Jingmen People's Hospital

    Jingmen, Hubei, 448000

    Wei Li

    Recruiting

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252000

    Liyong Zhang

    Recruiting

  • Liaocheng Third People's Hospital

    Liaocheng, Shandong, 252000

    Lei Yang

    Recruiting

  • The People's Hospital of Gaotang

    Liaocheng, Shandong, 252800

    Huqing Li

    Recruiting

  • Feixian People's Hospital

    Linyi, Shandong, 273400

    Suspended

  • Luoyang Yanshi People's Hospital

    Luoyang, Henan, 471000

    Yang Zhou

    Recruiting

  • Mianyang third people's hospital

    Mianyang, Sichuan, 621000

    Hongxia Yang

    Recruiting

  • The Second Nanning People's Hospital

    Nanning, Guangxi, 530000

    Tong Li

    Recruiting

  • Nanyang Central Hospital

    Nanyang, Henan, 473000

    Changming Wen

    Recruiting

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong, 518000

    Pengcheng Fu

    Not yet recruiting

  • South China Hospital Affiliated to Shenzhen University

    Shenzhen, Guangdong, 518000

    Shiwei Du

    Recruiting

  • Army Medical University Noncommissioned Officer School Affiliated Hospital

    Shijiazhuang, Hebei, 050047

    Jin Li

    Recruiting

  • Hebei General Hospital

    Shijiazhuang, Hebei, 455001

    Guodong Xu

    Not yet recruiting

  • Suzhou Municipal Hospital of Anhui Province

    Suzhou, Anhui, 234000

    Lei Zhang

    Recruiting

  • The Fourth Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000

    Qi Fang

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Qi Fang

    Recruiting

  • Taihe County People's Hospital

    Taihe Chengguanzhen, Anhui, 236600

    Tao Cui

    Recruiting

  • First People's Hospital of Tianmen

    Tianmen, Hubei, 430000

    Suspended

  • Tongling People's Hospital

    Tongling, Anhui

    Tao Wang

    Recruiting

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Bo Yin

    Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430000

    Huagang Li, 8617762473010

    Recruiting

  • The Third People's Hospital of Hubei Province

    Wuhan, Hubei, 430033

    Yue Wan

    Not yet recruiting

  • The Central Hospital of Xiangtan

    Xiangtan, Hunan, 411100

    Guangxiong Yuan

    Not yet recruiting

  • Ya 'an People's Hospital

    Ya'an, Sichuan, 625000

    Jian Wang

    Recruiting

  • Yeda Hospital

    Yantai, Shandong

    Wenjun Qian

    Recruiting

  • Yichang Central People's Hospital

    Yichang, Hubei, 443000

    Huajun Zhou

    Recruiting

  • Yueqing People's Hospital

    Yueqing, Zhejiang, 325600

    Saizhen Wu

    Recruiting

  • Zhangzhou Municipal Hospital of Fujian Province

    Zhangzhou, Fujian, 363000

    Tingyu Yi

    Recruiting

  • Henan Province People's Hospital

    Zhengzhou, Henan, 450000

    Liangfu Zhu

    Not yet recruiting

  • Xihua county people's hospital

    Zhoukou, Henan, 466600

    Chaoqun Li

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Being tested
14-day remote ischemic conditioning, 30-day remote ischemic conditioning, Endovascular thrombectomy, Best medical management
Keywords
Endovascular thrombectomy, Cerebroprotection, Remote ischemic conditioning
Medical subject headings
Ischemic Stroke, Brain Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 14-day remote ischemic conditioningDevice

    Also called 14-day RIC

    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 conditioningDevice

    Also called 30-day RIC

    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 thrombectomyProcedure or surgery

    Also called EVT

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

  • Best medical managementDrug

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

Study groups in NCT06559241
Study groupRoleWhat they receive
Control groupOtherPatients in the control group will receive endovascular thrombectomy and the best medical management according to the guidelines.
Receives: Procedure: Endovascular thrombectomy; Drug: Best medical management
14-day treatment groupExperimentalPatients 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.
Receives: Device: 14-day remote ischemic conditioning; Procedure: Endovascular thrombectomy; Drug: Best medical management
30-day treatment groupExperimentalPatients 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.
Receives: Device: 30-day remote ischemic conditioning; Procedure: Endovascular thrombectomy; Drug: Best medical management

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 90 days after stroke.

Secondary outcomes (13)

  1. 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).

    The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.

    Measured: 90 days after stroke.

  2. The ordinal distribution of mRS scores at 90 days.

    The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.

    Measured: 90 days after stroke.

  3. The proportion of patients with early neurological improvement 24 hours after endovascular procedures.

    The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes. Neurological improvement is defined as the NIHSS recovering to ≤2 points or decreasing by 8 points or much higher as compared with the baseline.

    Measured: 24 hours after endovascular procedures.

  4. Changes in NIHSS score from baseline to day 14 or at discharge (whichever comes earlier).

    The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes.

    Measured: 14 days or at discharge (whichever comes first)

  5. Score of EQ-5D-5L at 90 days.

    EQ-5D-5L is a tool used to assess health status, including five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A higher score indicates a better health status, while a lower score indicates a poorer health status.

    Measured: 90 days after stroke.

  6. Cerebral infarct volume.

    The infarction volume will be assessed on cranial CT or MRI imaging.

    Measured: 72 hours after endovascular procedures.

  7. The change of infarct volume.

    Infarct Expansion Ratio (IER, IER=infarct volume/baseline infarct volume). The infarction volume will be assessed on cranial CT or MRI imaging, and baseline infarct volume will be assessed on the CTP or baseline MRI imaging.

    Measured: 72 hours after endovascular procedures.

  8. Incidence of intracranial hemorrhage.

    Intracranial hemorrhage is defined as the demonstration of hemorrhage within brain parenchyma on head imaging, according to the criteria of the ECASS III.

    Measured: Within 14 days after endovascular procedures.

  9. Incidence of Symptomatic Intracranial Hemorrhage

    Symptomatic intracranial hemorrhage is defined as the demonstration of hemorrhage within brain parenchyma on head imaging leading to an increase of at least 4 points in the NIHSS score, according to the criteria of the European Cooperative Acute Stroke Study III (ECASS III).

    Measured: Within 14 days after endovascular procedures.

  10. Incidence of neurological deterioration within 14 days.

    Neurological deterioration is defined as an increase of ≥4 points in NIHSS compared to before deterioration within 14 days.

    Measured: Within 14 days after endovascular procedures.

  11. Incidence of malignant infarction

    Malignant infarction is defined as infarction involving more than half of the affected middle cerebral artery area, a significant mass effect requiring decompressive craniectomy, and/or directly leading to death with clinical signs of brain herniation.

    Measured: 0-90 days

  12. All cause of death.

    The incidence of death events at any time from randomization through day 90.

    Measured: 0-90 days

  13. Incidence of Adverse Events/Serious Adverse Events

    The incidence of other adverse events and serious adverse events at any time from randomization through day 90.

    Measured: 0-90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2024
  2. Study start23 Sep 2024
  3. Primary completionNov 2026 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06559241
Sponsor's protocol ID
RECAST-MT
Acronym
RECAST-MT
Status last verified
Dec 2025
First submitted
4 Aug 2024
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 28174194

  • 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.

    PubMed 32166195

  • 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.

    PubMed 33028663

  • 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. 2026 Aug 27;11(4):484-489. doi: 10.1136/svn-2025-004591.

    PubMed 41290408

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 14-day remote ischemic conditioning, 30-day remote ischemic conditioning and Endovascular thrombectomy in people with Acute Ischemic Stroke and Anterior Circulation Brain Infarction, run by Capital Medical University at 56 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xunming Ji, MD, PhD (010-8319-9439, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 90 days. (time frame: 90 days after stroke.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06559241, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

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