Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Other | Patients in the control group will receive endovascular thrombectomy and the best medical management according to the guidelines. |
|
| 14-day treatment group | Experimental | 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. |
|
| 30-day treatment group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14-day remote ischemic conditioning | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xunming Ji, MD, PhD | Contact | 010-8319-9439 | jixm@ccmu.edu.cn | |
| Sijie Li, MD | Contact | +8613581610258 | lisijie@xwh.ccmu.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suzhou Municipal Hospital of Anhui Province | Recruiting | Suzhou | Anhui | 234000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28174194 | Result | 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. | |
| 32166195 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 30-day remote ischemic conditioning | Device | 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 thrombectomy | Procedure | Endovascular thrombectomy procedures are performed according to the guidelines to recanalize the occluded large vessel safely. |
|
|
| Best medical management | Drug | Best medical management is prescribed at the discretion of the treating physicians according to the guidelines. |
|
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 |
| Taihe County People's Hospital | Recruiting | Taihe Chengguanzhen | Anhui | 236600 | China |
|
| Tongling People's Hospital | Recruiting | Tongling | Anhui | China |
|
| Beijing Luhe Hospital affiliated to Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100000 | China |
|
| Beijing Fangshan District First Hospital | Recruiting | Beijing | Beijing Municipality | 100010 | China |
|
| Fujian Provincial Hospital | Not yet recruiting | Fuzhou | Fujian | 350028 | China |
|
| Zhangzhou Municipal Hospital of Fujian Province | Recruiting | Zhangzhou | Fujian | 363000 | China |
|
| Shenzhen Second People's Hospital | Not yet recruiting | Shenzhen | Guangdong | 518000 | China |
|
| South China Hospital Affiliated to Shenzhen University | Recruiting | Shenzhen | Guangdong | 518000 | China |
|
| The Second Nanning People's Hospital | Recruiting | Nanning | Guangxi | 530000 | China |
|
| Cangzhou Central Hospital | Recruiting | Cangzhou | Hebei | 061000 | China |
|
| Army Medical University Noncommissioned Officer School Affiliated Hospital | Recruiting | Shijiazhuang | Hebei | 050047 | China |
|
| Hebei General Hospital | Not yet recruiting | Shijiazhuang | Hebei | 455001 | China |
|
| The Hongda Hospital of Jiamusi University | Recruiting | Jiamusi | Heilongjiang | 154000 | China |
|
| Xunxian People's Hospital | Recruiting | Hebi | Henan | 456250 | China |
|
| Jiaozuo Coal Industry Group Co., Ltd. Central Hospital | Recruiting | Jiaozuo | Henan | 454000 | China |
|
| Luoyang Yanshi People's Hospital | Recruiting | Luoyang | Henan | 471000 | China |
|
| Nanyang Central Hospital | Recruiting | Nanyang | Henan | 473000 | China |
|
| Henan Province People's Hospital | Not yet recruiting | Zhengzhou | Henan | 450000 | China |
|
| Xihua county people's hospital | Recruiting | Zhoukou | Henan | 466600 | China |
|
| Huanggang Central hospital | Recruiting | Huanggang | Hubei | 438000 | China |
|
| Huangshi central hospital | Recruiting | Huangshi | Hubei | 435000 | China |
|
| Jingmen Central hospital | Recruiting | Jingmen | Hubei | 448000 | China |
|
| Jingmen People's Hospital | Recruiting | Jingmen | Hubei | 448000 | China |
|
| First People's Hospital of Tianmen | Suspended | Tianmen | Hubei | 430000 | China |
| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430000 | China |
|
| The Third People's Hospital of Hubei Province | Not yet recruiting | Wuhan | Hubei | 430033 | China |
|
| Yichang Central People's Hospital | Recruiting | Yichang | Hubei | 443000 | China |
|
| the First People's Hospital of Changde | Recruiting | Changde | Hunan | 415000 | China |
|
| The Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410000 | China |
|
| the First People's Hospital of Chenzhou | Not yet recruiting | Chenzhou | Hunan | 423000 | China |
|
| The Central Hospital of Xiangtan | Not yet recruiting | Xiangtan | Hunan | 411100 | China |
|
| Inner Mongolia Autonomous Region People's Hospital | Not yet recruiting | Hohhot | Inner Mongolia | 010000 | China |
|
| The Fourth Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
|
| Anshan Changda Hospital | Recruiting | Anshan | Liaoning | Anshan | China |
|
| Dalian Central Hospital | Not yet recruiting | Dalian | Liaoning | 116000 | China |
| The First Affiliated Hospital of Dalian Medical University | Recruiting | Dalian | Liaoning | 116000 | China |
|
| Shengli Oilfield Central Hospital | Recruiting | Dongying | Shandong | 257000 | China |
|
| Jinan Third People's Hospital | Recruiting | Jinan | Shandong | 250000 | China |
|
| Liaocheng People's Hospital | Recruiting | Liaocheng | Shandong | 252000 | China |
|
| Liaocheng Third People's Hospital | Recruiting | Liaocheng | Shandong | 252000 | China |
|
| The People's Hospital of Gaotang | Recruiting | Liaocheng | Shandong | 252800 | China |
|
| Feixian People's Hospital | Suspended | Linyi | Shandong | 273400 | China |
| Yeda Hospital | Recruiting | Yantai | Shandong | China |
|
| Mianyang third people's hospital | Recruiting | Mianyang | Sichuan | 621000 | China |
|
| Ya 'an People's Hospital | Recruiting | Ya'an | Sichuan | 625000 | China |
|
| The Second Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325000 | China |
|
| Yueqing People's Hospital | Recruiting | Yueqing | Zhejiang | 325600 | China |
|
| Beijing Chao-Yang Hospital | Recruiting | Beijing | 100020 | China |
|
| Aerospace Central Hospital | Recruiting | Beijing | 100049 | China |
|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | 100053 | China |
|
| Beijing Fengtai You'anmen Hospital | Recruiting | Beijing | 100071 | China |
|
| Beijing Red Cross Emergency Medical Center | Recruiting | Beijing | 100085 | China |
|
| Beijing Daxing District People's Hospital | Recruiting | Beijing | 102600 | China |
|
| Chongqing University Fuling Hospital | Not yet recruiting | Chongqing | 408000 | China |
|
| Result |
| 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. |
| 33028663 | Result | 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. |
| 41290408 | Derived | 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. 2025 Nov 25:svn-2025-004591. doi: 10.1136/svn-2025-004591. Online ahead of print. |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020520 | Brain Infarction |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided