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机械血栓切除术治疗急性缺血性中风的远程缺血调理（RECAST-MT） (RECAST-MT)

2026年11月4日 更新者：Ji Xunming,MD,PhD、Capital Medical University

机械血栓切除术治疗急性缺血性中风的远程缺血调理 (RECAST-MT) 的安全性和有效性：一项多中心、随机、对照、开放标签、盲态终点试验

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

2105

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Xunming Ji, MD, PhD
  • 电话号码：010-8319-9439
  • 邮箱：jixm@ccmu.edu.cn

研究联系人备份

学习地点

  • 中国
      • Beijing、中国、100053
        • 招聘中
        • Xuanwu Hospital, Capital Medical University
        • 接触：
        • 接触：
      • Beijing、中国、100020
        • 招聘中
        • Beijing Chao-Yang Hospital
        • 接触：
          • Yang Wang
      • Beijing、中国、100049
        • 招聘中
        • Aerospace Central Hospital
        • 接触：
          • Peifu Wang
      • Beijing、中国、100071
        • 招聘中
        • Beijing Fengtai You'anmen Hospital
        • 接触：
          • Jing Wang
      • Beijing、中国、100085
        • 招聘中
        • Beijing Red Cross Emergency Medical Center
        • 接触：
          • Guohui Zhao
      • Beijing、中国、102600
        • 招聘中
        • Beijing Daxing District People's Hospital
        • 接触：
          • Jinglin Yuan
      • Chongqing、中国、408000
        • 尚未招聘
        • Chongqing University Fuling Hospital
        • 接触：
          • Tao Wang
    • Anhui
      • Suzhou、Anhui、中国、234000
        • 招聘中
        • Suzhou Municipal Hospital of Anhui Province
        • 接触：
          • Lei Zhang
      • Taihe Chengguanzhen、Anhui、中国、236600
        • 招聘中
        • Taihe County People's Hospital
        • 接触：
          • Tao Cui
      • Tongling、Anhui、中国
        • 招聘中
        • Tongling People's Hospital
        • 接触：
          • Tao Wang
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100010
        • 招聘中
        • Beijing Fangshan District First Hospital
        • 接触：
          • Liang Chen
      • Beijing、Beijing Municipality、中国、100000
        • 招聘中
        • Beijing Luhe Hospital affiliated to Capital Medical University
        • 接触：
          • Xiaokun Geng
    • Fujian
      • Fuzhou、Fujian、中国、350028
        • 尚未招聘
        • Fujian Provincial Hospital
        • 接触：
          • Qiong Cheng
      • Zhangzhou、Fujian、中国、363000
        • 招聘中
        • Zhangzhou Municipal Hospital of Fujian Province
        • 接触：
          • Tingyu Yi
    • Guangdong
      • Heyuan、Guangdong、中国、517000
        • 招聘中
        • Heyuan People's Hospital
        • 接触：
          • Guanghong Zhong
      • Huizhou、Guangdong、中国、516000
        • 招聘中
        • Huizhou Third People's Hospital
        • 接触：
          • Jinjin Yan
      • Shenzhen、Guangdong、中国、518000
        • 尚未招聘
        • Shenzhen Second People's Hospital
        • 接触：
          • Pengcheng Fu
      • Shenzhen、Guangdong、中国、518000
        • 招聘中
        • South China Hospital Affiliated to Shenzhen University
        • 接触：
          • Shiwei Du
    • Guangxi
      • Nanning、Guangxi、中国、530000
        • 招聘中
        • The Second Nanning People's Hospital
        • 接触：
          • Tong Li
      • Qinzhou、Guangxi、中国、535000
        • 招聘中
        • Qinzhou Second People's Hospital
        • 接触：
          • Caixia Xuan
    • Hainan
      • Haikou、Hainan、中国、570100
        • 招聘中
        • The Second Affiliated Hospital of Hainan Medical University
        • 接触：
          • Bin Chen
    • Hebei
      • Cangzhou、Hebei、中国、061000
        • 招聘中
        • Cangzhou Central Hospital
        • 接触：
          • Yongchang Liu
      • Shijiazhuang、Hebei、中国、050047
        • 招聘中
        • Army Medical University Noncommissioned Officer School Affiliated Hospital
        • 接触：
          • Jin Li
      • Tangshan、Hebei、中国、063000
        • 招聘中
        • Kailuan General Hospital
        • 接触：
          • Yesong Liu
    • Heilongjiang
      • Harbin、Heilongjiang、中国
        • 招聘中
        • The First Affiliated Hospital of Harbin Medical University
        • 接触：
          • Hongquan Jiang
      • Jiamusi、Heilongjiang、中国、154000
        • 招聘中
        • The Hongda Hospital of Jiamusi University
        • 接触：
          • Changsi Ai
    • Henan
      • Hebi、Henan、中国、456250
        • 招聘中
        • Xunxian People's Hospital
        • 接触：
          • Beihai Jiang
      • Jiaozuo、Henan、中国、454000
        • 招聘中
        • Jiaozuo Coal Industry Group Co., Ltd. Central Hospital
        • 接触：
          • Qianqian Qiu
      • Luoyang、Henan、中国、471000
        • 招聘中
        • Luoyang Yanshi People's Hospital
        • 接触：
          • Yang Zhou
      • Luoyang、Henan、中国、471000
        • 招聘中
        • the first people's hospital of Luoyang
        • 接触：
          • Jinfeng Shi
      • Nanyang、Henan、中国、473000
        • 招聘中
        • Nanyang Central Hospital
        • 接触：
          • Changming Wen
      • Nanyang、Henan、中国、473000
        • 招聘中
        • Nanyang Nanshi Hospital
        • 接触：
          • Shuai Zhu
      • Shangqiu、Henan、中国、476000
        • 招聘中
        • Shangqiu First People's Hospital
        • 接触：
          • Quande Dai
      • Zhengzhou、Henan、中国、450000
        • 尚未招聘
        • Henan Province People's Hospital
        • 接触：
          • Liangfu Zhu
      • Zhoukou、Henan、中国、466600
        • 招聘中
        • Xihua county people's hospital
        • 接触：
          • Chaoqun Li
    • Hubei
      • Huanggang、Hubei、中国、438000
        • 招聘中
        • Huanggang Central hospital
        • 接触：
          • Jiajun Wang
      • Huangshi、Hubei、中国、435000
        • 招聘中
        • Huangshi central hospital
        • 接触：
          • Chensong Deng
      • Jingmen、Hubei、中国、448000
        • 招聘中
        • Jingmen People's Hospital
        • 接触：
          • Wei Li
      • Jingmen、Hubei、中国、448000
        • 招聘中
        • Jingmen Central hospital
        • 接触：
          • Ying Wei
      • Tianmen、Hubei、中国、430000
        • 暂停
        • First People's Hospital of Tianmen
      • Wuhan、Hubei、中国、430000
        • 招聘中
        • Zhongnan Hospital of Wuhan University
        • 接触：
          • Huagang Li
          • 电话号码：8617762473010
      • Wuhan、Hubei、中国、430033
        • 尚未招聘
        • The Third People's Hospital of Hubei Province
        • 接触：
          • Yue Wan
      • Xiangyang、Hubei、中国
        • 招聘中
        • Xiangyang Central Hospital
        • 接触：
          • Jing Yang
      • Yichang、Hubei、中国、443000
        • 招聘中
        • Yichang Central People's Hospital
        • 接触：
          • Huajun Zhou
    • Hunan
      • Changde、Hunan、中国、415000
        • 招聘中
        • Changde First Hospital of Traditional Chinese Medicine
        • 接触：
          • Weiwu Hu
      • Changde、Hunan、中国、415000
        • 招聘中
        • the First People's Hospital of Changde
        • 接触：
          • Jun Wen
      • Changde、Hunan、中国、415700
        • 招聘中
        • Taoyuan County People's Hospital
        • 接触：
          • Hui Tan
      • Changsha、Hunan、中国、410000
        • 招聘中
        • The Third Xiangya Hospital of Central South University
        • 接触：
          • Yi Yuan
      • Chenzhou、Hunan、中国、423000
        • 尚未招聘
        • the First People's Hospital of Chenzhou
        • 接触：
          • Xiaoxi Yao
      • Xiangtan、Hunan、中国、411100
        • 尚未招聘
        • The Central Hospital of Xiangtan
        • 接触：
          • Guangxiong Yuan
    • Inner Mongolia
      • Hohhot、Inner Mongolia、中国、010000
        • 尚未招聘
        • Inner Mongolia Autonomous Region People's Hospital
        • 接触：
          • Dong Wang
    • Jiangsu
      • Suzhou、Jiangsu、中国、215006
        • 招聘中
        • The First Affiliated Hospital of Soochow University
        • 接触：
          • Qi Fang
      • Suzhou、Jiangsu、中国、215000
        • 招聘中
        • The Fourth Affiliated Hospital of Soochow University
        • 接触：
          • Qi Fang
      • Xuzhou、Jiangsu、中国、221000
        • 招聘中
        • The Affiliated Hospital of Xuzhou Medical University
        • 接触：
          • Yu Feng
    • Liaoming
      • Dalian、Liaoming、中国、116011
        • 招聘中
        • The First Affiliated Hospital of Dalian Medical University
        • 接触：
          • Ke Li
    • Liaoning
      • Anshan、Liaoning、中国、Anshan
        • 招聘中
        • Anshan Changda Hospital
        • 接触：
          • Fan Zhang
      • Dalian、Liaoning、中国、116000
        • 招聘中
        • The First Affiliated Hospital of Dalian Medical University
        • 接触：
          • Ke Li
    • Shandong
      • Dongying、Shandong、中国、257000
        • 招聘中
        • Shengli Oilfield Central Hospital
        • 接触：
          • Ye Lang
      • Jinan、Shandong、中国、250000
        • 招聘中
        • Jinan Third People's Hospital
        • 接触：
          • Yan Li
      • Liaocheng、Shandong、中国、252000
        • 招聘中
        • Liaocheng People's Hospital
        • 接触：
          • Liyong Zhang
      • Liaocheng、Shandong、中国、252000
        • 招聘中
        • Liaocheng Third People's Hospital
        • 接触：
          • Lei Yang
      • Liaocheng、Shandong、中国、252800
        • 招聘中
        • The People's Hospital of Gaotang
        • 接触：
          • Huqing Li
      • Linyi、Shandong、中国、273400
        • 暂停
        • Feixian People's Hospital
      • Yantai、Shandong、中国
        • 招聘中
        • Yeda Hospital
        • 接触：
          • Wenjun Qian
    • Shannxi
      • Weinan、Shannxi、中国、714000
        • 招聘中
        • Weinan Central Hospital
        • 接触：
          • Zhen Yang
    • Sichuan
      • Chengdu、Sichuan、中国、610017
        • 招聘中
        • Chengdu Second People's Hospital
        • 接触：
          • Jian Wang
      • Mianyang、Sichuan、中国、621000
        • 招聘中
        • Mianyang third people's hospital
        • 接触：
          • Hongxia Yang
      • Ya'an、Sichuan、中国、625000
        • 招聘中
        • Ya 'an People's Hospital
        • 接触：
          • Jian Wang
    • Zhejiang
      • Wenzhou、Zhejiang、中国、325000
        • 招聘中
        • The Second Affiliated Hospital of Wenzhou Medical University
        • 接触：
          • Bo Yin
      • Yueqing、Zhejiang、中国、325600
        • 招聘中
        • Yueqing People's Hospital
        • 接触：
          • Saizhen Wu

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
其他：Control group

Patients in the control group will receive endovascular thrombectomy and the best medical management according to the guidelines.
程序：Endovascular thrombectomy

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

其他名称：
  • EVT
药品：Best medical management

Best medical management is prescribed at the discretion of the treating physicians according to the guidelines.
实验性的：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.
程序：Endovascular thrombectomy

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

其他名称：
  • EVT
药品：Best medical management

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

设备：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.

其他名称：
  • 14 天 RIC
实验性的：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.
程序：Endovascular thrombectomy

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

其他名称：
  • EVT
药品：Best medical management

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

设备：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.

其他名称：
  • 30 天 RIC

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
The proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 90 days.
大体时间：90 days after stroke.

The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
90 days after stroke.

次要结果测量

结果测量
措施说明
大体时间
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).
大体时间：90 days after stroke.

The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
90 days after stroke.
The ordinal distribution of mRS scores at 90 days.
大体时间：90 days after stroke.

The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
90 days after stroke.
The proportion of patients with early neurological improvement 24 hours after endovascular procedures.
大体时间：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.
24 hours after endovascular procedures.
Changes in NIHSS score from baseline to day 14 or at discharge (whichever comes earlier).
大体时间：14 days or at discharge (whichever comes first)

The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes.
14 days or at discharge (whichever comes first)
Score of EQ-5D-5L at 90 days.
大体时间：90 days after stroke.

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.
90 days after stroke.
Cerebral infarct volume.
大体时间：72 hours after endovascular procedures.

The infarction volume will be assessed on cranial CT or MRI imaging.
72 hours after endovascular procedures.
The change of infarct volume.
大体时间：72 hours after endovascular procedures.

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.
72 hours after endovascular procedures.
Incidence of intracranial hemorrhage.
大体时间：Within 14 days after endovascular procedures.

Intracranial hemorrhage is defined as the demonstration of hemorrhage within brain parenchyma on head imaging, according to the criteria of the ECASS III.
Within 14 days after endovascular procedures.
Incidence of Symptomatic Intracranial Hemorrhage
大体时间：Within 14 days after endovascular procedures.

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).
Within 14 days after endovascular procedures.
Incidence of neurological deterioration within 14 days.
大体时间：Within 14 days after endovascular procedures.

Neurological deterioration is defined as an increase of ≥4 points in NIHSS compared to before deterioration within 14 days.
Within 14 days after endovascular procedures.
Incidence of malignant infarction
大体时间：0-90 days

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.
0-90 days
All cause of death.
大体时间：0-90 days

The incidence of death events at any time from randomization through day 90.
0-90 days
Incidence of Adverse Events/Serious Adverse Events
大体时间：0-90 days

The incidence of other adverse events and serious adverse events at any time from randomization through day 90.
0-90 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Capital Medical University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年9月23日

初级完成 (估计的)

2026年11月1日

研究完成 (估计的)

2027年2月1日

研究注册日期

首次提交

2024年8月4日

首先提交符合 QC 标准的

2024年8月16日

首次发布 (实际的)

2024年8月19日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月4日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • RECAST-MT

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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