Ekstern iskemisk kondisjonering for akutt iskemisk hjerneslag behandlet med mekanisk trombektomi (RECAST-MT) (RECAST-MT)
Sikkerhet og effekt av fjern iskemisk kondisjonering for akutt iskemisk hjerneslag behandlet med mekanisk trombektomi (RECAST-MT): Et multisenter, randomisert, kontrollert, åpent, blindt endepunktsforsøk
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.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Xunming Ji, MD, PhD
- Telefonnummer: 010-8319-9439
- E-post: jixm@ccmu.edu.cn
Studer Kontakt Backup
- Navn: Sijie Li, MD
- Telefonnummer: +8613581610258
- E-post: lisijie@xwh.ccmu.edu.cn
Studiesteder
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-
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Beijing, Kina, 100053
- Rekruttering
- Xuanwu Hospital, Capital Medical University
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Ta kontakt med:
- Xunming Ji, MD, PhD
- Telefonnummer: 010-83199430
- E-post: jixm@ccmu.edu.cn
-
Ta kontakt med:
- Sijie Li, MD
- Telefonnummer: 86-13581610258
- E-post: lisijie@xwh.ccmu.edu.cn
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Beijing, Kina, 100020
- Rekruttering
- Beijing Chao-Yang Hospital
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Ta kontakt med:
- Yang Wang
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Beijing, Kina, 100049
- Rekruttering
- Aerospace Central Hospital
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Ta kontakt med:
- Peifu Wang
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Beijing, Kina, 100071
- Rekruttering
- Beijing Fengtai You'anmen Hospital
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Ta kontakt med:
- Jing Wang
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Beijing, Kina, 100085
- Rekruttering
- Beijing Red Cross Emergency Medical Center
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Ta kontakt med:
- Guohui Zhao
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Beijing, Kina, 102600
- Rekruttering
- Beijing Daxing District People's Hospital
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Ta kontakt med:
- Jinglin Yuan
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Chongqing, Kina, 408000
- Har ikke rekruttert ennå
- Chongqing University Fuling Hospital
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Ta kontakt med:
- Tao Wang
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Anhui
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Suzhou, Anhui, Kina, 234000
- Rekruttering
- Suzhou Municipal Hospital of Anhui Province
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- Lei Zhang
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Taihe Chengguanzhen, Anhui, Kina, 236600
- Rekruttering
- Taihe County People's Hospital
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Ta kontakt med:
- Tao Cui
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Tongling, Anhui, Kina
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- Tao Wang
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100010
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- Liang Chen
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Beijing, Beijing Municipality, Kina, 100000
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- Xiaokun Geng
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Fujian
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Fuzhou, Fujian, Kina, 350028
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Zhangzhou, Fujian, Kina, 363000
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Guangdong
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Heyuan, Guangdong, Kina, 517000
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Huizhou, Guangdong, Kina, 516000
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Shenzhen, Guangdong, Kina, 518000
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Shenzhen, Guangdong, Kina, 518000
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- South China Hospital Affiliated to Shenzhen University
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Guangxi
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Nanning, Guangxi, Kina, 530000
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Qinzhou, Guangxi, Kina, 535000
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Hainan
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Haikou, Hainan, Kina, 570100
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Hebei
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Cangzhou, Hebei, Kina, 061000
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Shijiazhuang, Hebei, Kina, 050047
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Tangshan, Hebei, Kina, 063000
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Heilongjiang
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Harbin, Heilongjiang, Kina
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Jiamusi, Heilongjiang, Kina, 154000
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Henan
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Hebi, Henan, Kina, 456250
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Jiaozuo, Henan, Kina, 454000
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Luoyang, Henan, Kina, 471000
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Luoyang, Henan, Kina, 471000
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- Jinfeng Shi
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Nanyang, Henan, Kina, 473000
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Ta kontakt med:
- Changming Wen
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Nanyang, Henan, Kina, 473000
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Ta kontakt med:
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Shangqiu, Henan, Kina, 476000
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Zhengzhou, Henan, Kina, 450000
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Zhoukou, Henan, Kina, 466600
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Ta kontakt med:
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Hubei
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Huanggang, Hubei, Kina, 438000
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Huangshi, Hubei, Kina, 435000
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Ta kontakt med:
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Jingmen, Hubei, Kina, 448000
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Ta kontakt med:
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Jingmen, Hubei, Kina, 448000
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Ta kontakt med:
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Tianmen, Hubei, Kina, 430000
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Wuhan, Hubei, Kina, 430000
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- Zhongnan Hospital of Wuhan University
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Ta kontakt med:
- Huagang Li
- Telefonnummer: 8617762473010
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Wuhan, Hubei, Kina, 430033
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- The Third People's Hospital of Hubei Province
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Xiangyang, Hubei, Kina
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Yichang, Hubei, Kina, 443000
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Ta kontakt med:
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Hunan
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Changde, Hunan, Kina, 415000
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- Weiwu Hu
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Changde, Hunan, Kina, 415000
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Changde, Hunan, Kina, 415700
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- Hui Tan
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Changsha, Hunan, Kina, 410000
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- Yi Yuan
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Chenzhou, Hunan, Kina, 423000
- Har ikke rekruttert ennå
- the First People's Hospital of Chenzhou
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Ta kontakt med:
- Xiaoxi Yao
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Xiangtan, Hunan, Kina, 411100
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- The Central Hospital of Xiangtan
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Ta kontakt med:
- Guangxiong Yuan
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Inner Mongolia
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Hohhot, Inner Mongolia, Kina, 010000
- Har ikke rekruttert ennå
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Ta kontakt med:
- Dong Wang
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Jiangsu
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Suzhou, Jiangsu, Kina, 215006
- Rekruttering
- The First Affiliated Hospital of Soochow University
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- Qi Fang
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Suzhou, Jiangsu, Kina, 215000
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- Qi Fang
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Xuzhou, Jiangsu, Kina, 221000
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- The Affiliated Hospital of Xuzhou Medical University
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Ta kontakt med:
- Yu Feng
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Liaoming
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Dalian, Liaoming, Kina, 116011
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Liaoning
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Anshan, Liaoning, Kina, Anshan
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- Anshan Changda Hospital
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Ta kontakt med:
- Fan Zhang
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Dalian, Liaoning, Kina, 116000
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- The First Affiliated Hospital of Dalian Medical University
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Ta kontakt med:
- Ke Li
-
-
Shandong
-
Dongying, Shandong, Kina, 257000
- Rekruttering
- Shengli Oilfield Central Hospital
-
Ta kontakt med:
- Ye Lang
-
Jinan, Shandong, Kina, 250000
- Rekruttering
- Jinan Third People's Hospital
-
Ta kontakt med:
- Yan Li
-
Liaocheng, Shandong, Kina, 252000
- Rekruttering
- Liaocheng People's Hospital
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Ta kontakt med:
- Liyong Zhang
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Liaocheng, Shandong, Kina, 252000
- Rekruttering
- Liaocheng Third People's Hospital
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Ta kontakt med:
- Lei Yang
-
Liaocheng, Shandong, Kina, 252800
- Rekruttering
- The People's Hospital of Gaotang
-
Ta kontakt med:
- Huqing Li
-
Linyi, Shandong, Kina, 273400
- Suspendert
- Feixian People's Hospital
-
Yantai, Shandong, Kina
- Rekruttering
- Yeda Hospital
-
Ta kontakt med:
- Wenjun Qian
-
-
Shannxi
-
Weinan, Shannxi, Kina, 714000
- Rekruttering
- Weinan Central Hospital
-
Ta kontakt med:
- Zhen Yang
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 610017
- Rekruttering
- Chengdu Second People's Hospital
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Ta kontakt med:
- Jian Wang
-
Mianyang, Sichuan, Kina, 621000
- Rekruttering
- Mianyang third people's hospital
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Ta kontakt med:
- Hongxia Yang
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Ya'an, Sichuan, Kina, 625000
- Rekruttering
- Ya 'an People's Hospital
-
Ta kontakt med:
- Jian Wang
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-
Zhejiang
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Wenzhou, Zhejiang, Kina, 325000
- Rekruttering
- The Second Affiliated Hospital of Wenzhou Medical University
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Ta kontakt med:
- Bo Yin
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Yueqing, Zhejiang, Kina, 325600
- Rekruttering
- Yueqing People's Hospital
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Ta kontakt med:
- Saizhen Wu
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: 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.
Andre navn:
Best medical management is prescribed at the discretion of the treating physicians according to the guidelines. |
|
Eksperimentell: 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.
Andre navn:
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.
Andre navn:
|
|
Eksperimentell: 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.
Andre navn:
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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 90 days.
Tidsramme: 90 days after stroke.
|
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes. |
90 days after stroke.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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).
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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).
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 0-90 days
|
The incidence of other adverse events and serious adverse events at any time from randomization through day 90. |
0-90 days
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RECAST-MT
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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