The First Hospital of Jilin University
Changchun, Jilin, 130000, China
NCT Number: NCT04980625
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Changchun, Jilin, 130000, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 months
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: 24 hours, 7 days
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. Ranged from 0 to 100, a high value represents a better outcome.
Time frame: 90±3 days
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 days
All adverse events through 90 days.
Time frame: 24 hours
Frequency of Hemorrhagic transformation within 24 hours after IVT.
Time frame: 90 days
Mortality within 90 days.
Time frame: 90 days
Stroke recurrence rate within 90 days.
Yi Yang
Other
Safety and Efficacy of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis for Acute Ischemic Stroke: A Multicenter, Randomized, Parallel-controlled Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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