Remote Ischemic Conditioning for Acute Ischemic Stroke Treated With Mechanical Thrombectomy（RECAST-MT）
NCT Number: NCT06559241
Acronym: RECAST-MT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Acute Ischemic Stroke|Anterior Circulation Brain Infarction
Interventions: DEVICE: 14-day remote ischemic conditioning|DEVICE: 30-day remote ischemic conditioning|PROCEDURE: Endovascular thrombectomy|DRUG: Best medical management
Sponsor: Capital Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2105
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-02
Locations: Beijing Luhe Hospital affiliated to Capital Medical University, Beijing, Beijing, 100000, China|Beijing Fangshan District First Hospital, Beijing, Beijing, 100010, China|Shenzhen qianhai shekou free trade zone hospital, Shenzhen, Guangdong, 518000, China|South China Hospital Affiliated to Shenzhen University, Shenzhen, Guangdong, 518000, China|Nanning Second People's Hospital, Nanning, Guangxi, 530000, China|Jiamusi university hongda hospital, Jiamusi, Heilongjiang, 154000, China|Jiaozuo Coal Industry Group Co., Ltd. Central Hospital, Jiaozuo, Henan, 454000, China|Luoyang Yanshi People's Hospital, Luoyang, Henan, 471000, China|Henan Province People's Hospital, Zhengzhou, Henan, 450000, China|Xihua county people's hospital, Zhoukou, Henan, 466600, China|Huanggang Centralhospital, Huanggang, Hubei, 438000, China|Huangshi central hospital, Huangshi, Hubei, 435000, China|Jingmen No.1 People's Hospital, Jingmen, Hubei, 448000, China|Jingmen people's hospital, Jingmen, Hubei, 448000, China|First People's Hospital of Tianmen, Tianmen, Hubei, 430000, China|Wuhan University Zhongnan Hospital, Wuhan, Hubei, 430000, China|The First People's Hospital of Xiangyang, Xiangyang, Hubei, 441000, China|Yichang Central People's Hospital, Yichang, Hubei, 443000, China|the First People'S Hospital of Changde, Changde, Hunan, 415000, China|The Third Xiangya Hospital of Central South University, Changsha, Hunan, 410000, China|Xiangya Hospital, Central South University, Changsha, Hunan, 410000, China|Inner Mongolia Autonomous Region People's Hospital, Hohhot, Inner Mongolia Autonomous Region, 010000, China|Anshan zhangda hospital, Anshan, Liaoning, Anshan, China|Dalian Central Hospital, Dalian, Liaoning, 116000, China|The Central Hospital of Shengli Oilfield, Dongying, Shandong, 257000, China|Liaocheng Third People's Hospital, Liaocheng, Shandong, 252000, China|The People's Hospital of Liaocheng Brain Hospital, Liaocheng, Shandong, 252000, China|Feixian county people's hospital, Linyi, Shandong, 273400, China|Mianyang third people's hospital, Mianyang, Sichuan, 621000, China|Ya 'an People's Hospital, Ya'an, Sichuan, 625000, China|Tianjin huanhu hospital, Tianjin, Tianjin, 300000, China|The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China|Xuanwu Hospital, Capital Medical University, Beijing, 100053, China

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. 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.

Primary Outcome Measures: 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., 90 days after stroke.
Secondary Outcome Measures: 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., 90 days after stroke.|The ordinal distribution of mRS scores at 90 days., 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., 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)., 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., 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., The infarction volume will be assessed on cranial CT or MRI imaging., 72 hours after endovascular procedures.|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., 72 hours after endovascular procedures.|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., Within 14 days after endovascular procedures.|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)., Within 14 days after endovascular procedures.|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., Within 14 days after endovascular procedures.|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., 0-90 days|All cause of death., The incidence of death events at any time from randomization through day 90., 0-90 days|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., 0-90 days