이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

기계적 혈전제거술(RECAST-MT)을 이용한 급성 허혈성 뇌졸중의 원격 허혈 조절 (RECAST-MT)

2026년 11월 4일 업데이트: Ji Xunming,MD,PhD, Capital Medical University

기계적 혈전제거술(RECAST-MT)로 치료된 급성 허혈성 뇌졸중에 대한 원격 허혈 조절의 안전성 및 유효성: 다기관, 무작위, 대조, 공개 라벨, 맹검 종점 시험

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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

2105

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Xunming Ji, MD, PhD
  • 전화번호: 010-8319-9439
  • 이메일: jixm@ccmu.edu.cn

연구 연락처 백업

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: Control group

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

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

다른 이름들:
  • EVT

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

실험적: 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.

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

다른 이름들:
  • EVT

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

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.

다른 이름들:
  • 14일 RIC
실험적: 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.

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

다른 이름들:
  • EVT

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

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.

다른 이름들:
  • 30일 RIC

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
The proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 90 days.
기간: 90 days after stroke.

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

90 days after stroke.

2차 결과 측정

결과 측정
측정값 설명
기간
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).
기간: 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.
기간: 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.
기간: 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).
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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
기간: 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.
기간: 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
기간: 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.
기간: 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
기간: 0-90 days

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

0-90 days

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연구 기록 날짜

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연구 주요 날짜

연구 시작 (실제)

2024년 9월 23일

기본 완료 (추정된)

2026년 11월 1일

연구 완료 (추정된)

2027년 2월 1일

연구 등록 날짜

최초 제출

2024년 8월 4일

QC 기준을 충족하는 최초 제출

2024년 8월 16일

처음 게시됨 (실제)

2024년 8월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 4일

마지막으로 확인됨

2026년 11월 1일

추가 정보

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기타 연구 ID 번호

  • RECAST-MT

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

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약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

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미국 FDA 규제 기기 제품 연구

아니

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