Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for acute ischemic stroke.

Detailed Description
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In this study, 2210 cases of ischemic stroke in 72 hours were 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 in treating acute ischemic stroke.

Official Title
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Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke: A Multicenter, Randomized, Parallel-controlled Clinical Trial

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Procedure: Remote ischemic conditioning
* Procedure: Sham remote ischemic conditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Age≥18 years, regardless of sex. 2) Patients with clinically definite diagnosis of acute ischemic stroke and able to commence RIC treatment within 72 hours of stroke onset. 3) Baseline NIHSS ≥ 4, ≤ 24. 4) Baseline mRS ≤ 2; 5) Signed and dated informed consent is obtained. Exclusion Criteria: 1) Patients who undergo thrombolytic therapy or endovascular treatment. 2) The patients who had the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture, or vascular injury in the upper limb. Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc. 3) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumors,s and other diseases involving the brain. 4) Pregnant or lactating women. 5) Previous remote ischemic conditioning therapy or similar treatment. 6) Severe hepatic and renal dysfunction. 7) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons. 8) Unwilling to be followed up or treated for poor compliance. 9) He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission. 10) Other conditions that the researchers think are not suitable for the group.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RIC+Standard medical treatment<br>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 consecutive days. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014. | Procedure: Remote ischemic conditioning<br>* 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.<br>|
| Placebo Comparator: Sham RIC+Standard medical treatment<br>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 consecutive days. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014. | Procedure: Sham remote ischemic conditioning<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institute of Health stroke scale (NIHSS) at 7 days, 30±3 days, 90±3 days from onset. | National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days, 30±3 days, 90±3 days from onset. Ranged from 0 to 42, a low value represents a better outcome. | 7days, 30±3 days, 90±3 days | 
| modified Rankin Scale (mRS) Score at 7 days, 30±3 days, 90±3 days from onset. | modified Rankin Scale (mRS) at 24 hours, 7 days, 30±3 days, 90±3 days from onset. Ranged from 0 to 6, a low value represents a better outcome. | 7days, 30±3 days, 90±3 days | 
| Barthel Index (BI) at 7 days, 30±3 days, 90±3 days from onset. | Barthel Index (BI) at 7 days, 30±3 days, 90±3 days from onset. Ranged from 0 to 100, a high value represents a better outcome. | 7days, 30±3 days, 90±3 days | 
| Proportion of patients with hemorrhagic transformation during hospitalization. | Proportion of patients with hemorrhagic transformation during hospitalization. | 7 days | 
| Frequency of adverse events during follow-up. | Severe adverse events through day-90 after the onset of acute ischemic stroke. | 90 days |