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The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.
In this study, 498 cases of ischemic stroke who undergo endovascular thrombectomy within 24 hours from the onset are included in 10 centers in China according to the principle of random, and parallel control. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 7 consecutive days. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 7 consecutive days. Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIC+Standard medical treatment | Active Comparator | RIC+Standard medical treatment Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 days after endovascular thrombectomy. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2018. |
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| Sham RIC+Standard medical treatment | Placebo Comparator | Sham RIC+Standard medical treatment Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 days after endovascular thrombectomy. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2018. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic conditioning | Procedure | Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with modified Rankin Scale (mRS) Score 0-2 | Proportion of patients with modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days (or discharge) after EVT. | National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days (or discharge) after EVT. Ranged from 0 to 42, a low value represents a better outcome. | 24 hours, 7 days (or discharge) |
| Barthel Index (BI) at 24 hours, 7 days (or discharge) after EVT. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin | 130000 | China |
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| Sham remote ischemic conditioning | Procedure | Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. |
|
Barthel Index (BI) at 24 hours, 7 days (or discharge) after EVT. Ranged from 0 to 100, a high value represents a better outcome. |
| 24 hours, 7 days (or discharge) |
| Proportion of patients with modified Rankin Scale (mRS) 0-1 | Proportion of patients with modified Rankin Scale (mRS) 0-1. Ranged from 0 to 6, a low value represents a better outcome. | 90±3 days |
| modified Rankin Scale (mRS) score distribution | modified Rankin Scale (mRS) score distribution | 90±3 days |
| Recanalization rate within 7 days after EVT | Recanalization rate within 7 days after EVT | 7 days |
| Early neurological deterioration at 7 days | Early neurological deterioration at 7 days | 7 days |
| Frequency of Hemorrhagic transformation within 7 days | Frequency of Hemorrhagic transformation within 7 days | 7 days |
| Frequency of symptomatic intracranial hemorrhage within 7 days | Frequency of symptomatic intracranial hemorrhage within 7 days | 7 days |
| Death within 90 days | Death within 90 days | 90±3 days |
| Frequency of adverse events within 90 days | Frequency of adverse events within 90 days | 90±3 days |
| Adverse events associated with remote ischemic conditioning within 90 days | Adverse events associated with remote ischemic conditioning within 90 days | 90±3 days |
| Frequency of serious adverse events within 90 days | Frequency of serious adverse events within 90 days | 90±3 days |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| 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 |
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