The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for acute ischemic stroke.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,210
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.
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.
The First Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGProportion 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.
Time frame: 3 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 7days, 30±3 days, 90±3 days
Proportion of patients with hemorrhagic transformation during hospitalization.
Proportion of patients with hemorrhagic transformation during hospitalization.
Time frame: 7 days
Frequency of adverse events during follow-up.
Severe adverse events through day-90 after the onset of acute ischemic stroke.
Time frame: 90 days
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