The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.
In this study, 558 cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from the onset are included in 18 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 combined with intravenous thrombolysis in treating acute ischemic stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
558
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 inflations 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 inflations of a blood pressure cuff to 60 mm Hg.
The First Hospital of Jilin University
Changchun, Jilin, China
Proportion of patients with Modified Rankin Scale (mRS) Score 0-1
Proportion of patients with Modified Rankin Scale (mRS) Score 0-1. Ranged from 0 to 6, a low value represents a better outcome.
Time frame: 3 months
National Institute of Health stroke scale (NIHSS) at 24 hours, and 7 days after IVT.
National Institute of Health stroke scale (NIHSS) at 24 hours, and 7 days after IVT. Ranged from 0 to 42, a low value represents a better outcome.
Time frame: 24 hours, 7 days
Barthel Index (BI) at 24 hours, and 7 days after IVT.
Barthel Index (BI) at 24 hours, and 7 days after IVT. Ranged from 0 to 100, a high value represents a better outcome.
Time frame: 24 hours, 7 days
Proportion of patients with modified Rankin Scale (mRS) Score 0-2 at 90±3 days after IVT.
Proportion of patients with modified Rankin Scale (mRS) Score 0-2 at 90±3 days after IVT. mRS: Ranged from 0 to 6, a low value represents a better outcome.
Time frame: 90±3 days
Frequency of adverse events during follow-up
All adverse events through 90 days.
Time frame: 90 days
Frequency of Hemorrhagic transformation within 24 hours after IVT.
Frequency of Hemorrhagic transformation within 24 hours after IVT.
Time frame: 24 hours
Mortality within 90 days.
Mortality within 90 days.
Time frame: 90 days
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Stroke recurrence rate within 90 days.
Stroke recurrence rate within 90 days.
Time frame: 90 days