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| Name | Class |
|---|---|
| Second Affiliated Hospital of Xi'an Jiaotong University | OTHER |
| Shaanxi Provincial People's Hospital | OTHER |
| Xijing Hospital | OTHER |
| Tang-Du Hospital |
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Endovascular treatment(ET)is an effective therapy for acute ischemic stroke(AIS) with great vessel obstruction. However, acute complications such as high postoperative perfusion injury, hemorrhagic transformation and restenosis resulted in functional independence in only about 50% of patients 90 days after interventional surgery. Therefore, it is very important to protect the neurologic function after emergency endovascular treatment. The investigators' previous studies have shown that combined with intravenous thrombolytic therapy and remote postconditioning(RIPC)can significantly improve the neurological impairment and short-term and long-term prognosis in patients with acute stroke. In this multicenter, randomized controlled trial, the investigators assumed patients with acute ischemic stroke who had successfully revascularization after ET might benefit from RIPC as well. Patients in the RIPC group had five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm after ET. The primary endpoint measure was the proportion of patients with a favorable recovery of nerve function deficient assessed by Modified Rankin Scale (mRS≤2) 90 days after surgery. Secondary endpoints included the following: (1) Symptom endpoints: Neurological intelligence and function scores, postoperative hemorrhagic transformation rate, etc. (2) Blood index test: postoperative inflammatory factors, neuron-specific enolase (NSE) and other indicators. (3) Imaging endpoints: MRI-FLAIR , TCD, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIPC | Experimental | Patients in the RIPC group not only receive foundational treatment but also have five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm using a RIPC device (IPC-906X; Beijing Renqiao Institute of Neuroscience, Beijing, China) after endovascular treatment while in-hospital. |
|
| foundational treatment group (FT) | Sham Comparator | Patients in the FT group only receive foundational treatment, including free radical elimination in the acute stage, blood pressure and blood glucose stabilization, and antiplatelet (aspirin or/and clopidogrel,100-300mg/d) and lipid-lowering (atorvastatin 20-60mg/d,rosuvastatin 10-20mg/d) drugs, during the study period without remote ischemic postconditioning after endovascular treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RIPC device (IPC-906X) | Device | Patients in the RIPC group will have five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm twice a day after Mechanical Thrombectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin scale (mRS) | The percentage of patients with a favorable outcome from baseline at 90 days and 180 days postoperatively, defined as a score of 0 or 2 on the modified Rankin scale (mRS)(Notes:mRS score from 0-6, higher scores mean worse outcome) | 7days, 90 days and 180 days after the surgery and at discharge |
| Measure | Description | Time Frame |
|---|---|---|
| The change of NIHSS score | The percentage of functional recovery from baseline at 90 days and 180 days postoperatively, as measured by the National Institute of Health Stroke Scale, short for NIHSS(Notes:NIHSS score from 0-42. higher scores mean worse outcome) | 7days, 90 days and 180 days after the surgery and at discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guogang Luo, MD | Contact | 0086-13991974085 | lguogang@163.com | |
| Meng Wei, MD | Contact | 0086-15991748135 | 67183723@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42267436 | Derived | Cheng Y, Chen W, Chang M, Han X, Yu J, Wei M, Qi Y, Song B, Yao L, Lv H, Jia Y, Zhang X, Zhang G, Qiu Z, Zuo Q, Li G, Zhang Y, Chen C, Ma W, Wang Y, Cheng S, Liu F, Han J, Luo G. Remote Ischemic Postconditioning in Endovascular Thrombectomy for Stroke: The EnTRIPS Randomized Clinical Trial. Stroke. 2026 Jun 10. doi: 10.1161/STROKEAHA.126.054857. Online ahead of print. |
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12/31/2023, for 1 year
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| OTHER |
| Xi'an No.3 Hospital | OTHER_GOV |
| Xi'an Gaoxin Hospital | OTHER |
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| foundational treatment | Drug | foundational treatment, including free radical elimination in the acute stage, blood pressure and blood glucose stabilization, and antiplatelet (aspirin or/and clopidogrel ) and lipid-lowering (statins) drugs |
|
| The change of Barthel Index |
The change of functional recovery from baseline at 90 days and 180 days postoperatively, as measured by the Barthel Index (Notes:Barthel Index score from 0-100. higher scores mean better outcome) |
| 7days, 90 days and 180 days after the surgery and at discharge |
| The change of Montreal Cognitive Assessment (MoCA) score | The change of cognitive recovery from baseline at 90 days and 180 days postoperatively, as measured by the MoCA (Notes:MoCA score from 0-30. higher scores mean better outcome) | 7days, 90 days and 180 days after the surgery and at discharge |
| The change of MMSE score | The change of cognitive recovery from baseline at 90 days and 180 days postoperatively, as measured by the MMSE(Notes:MMSE score from 0-30. higher scores mean better outcome) | 7days, 90 days and 180 days after the surgery and at discharge |
| The change of inflammatory indicators | Peripheral venous blood was drawn before Endovascular Treatment(ET) and 24 hours and 7 days postoperatively to determine the effect of repeated RIPC on anti-inflammatory (hIL-1β、hIL-2R、hIL-6、hIL8、hIL-10、S100-β、TNF-α) (Notes: unit ng/ml) | before ET, 24 hours and 7 days after the surgery |
| The change of angiogenic factors | Peripheral venous blood was drawn before ET and 24 hours and 7 days postoperatively to determine the effect of repeated RIPC on vascular (VEGF、bFGF、EPO、HIF-1α、BDNF) and other pathways (S100B、NSE)(Notes: unit ng/ml) | before ET, 24 hours and 7 days after the surgery |
| The change of hemoglobin and Blood viscosity | Peripheral venous blood was drawn before ET and 24 hours and 7 days postoperatively to determine the effect of repeated RIPC on Hb and Blood viscosity(Notes: unit g/L , mPa.s) | up to 7 days after the surgery |
| Postoperative hemorrhagic transformation | The proportion of patients with postoperative hemorrhagic transformation, based on CT scan and symptom | 72 hours after ET and hospitalization |
| The change of MRI FLAIR Fazekas score | Cerebral white matter demyelination measured by MRI FLAIR Fazekas score,(Notes:Fazekas score from 0-6. higher scores mean worse outcome) | the changs from within 7 days to 90 days after the surgery |
| The change of blood flow velocity | Vascular blood flow velocity measured by transcranial doppler (TCD) examination | the changs from 24 hours after ET to 7 days after the surgery |
| Vascular resistance | Vascular resistance measured by TCD examination | the changs from 24 hours after ET to 7 days after the surgery |
| mortality rate | 90-days and 180-days mortality rate | up to 90 days and 180 days |
| recurrence rate of cerebrovascular disease | 90-days and 180-days recurrence rate of cerebrovascular disease | up to 90 days and 180 days |
| blood pressure | The effect of RIPC on blood pressure | up to 7days |
| heart rate | The effect of RIPC on heart rate | up to 7days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |