The First Hospital of Jilin University
Changchun, Jilin, 130000, China
NCT Number: NCT04027621
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–80 year
All sexes
Interventional
Not applicable
Changchun, Jilin, 130000, China
In this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times within 6 hours to 24 hours from thrombolysis. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times within 6 hours to 24 hours from thrombolysis . 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 re-perfusion. 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 re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.
Time frame: 7 days
All adverse events until day-7 or discharge (whichever is earlier)
Time frame: 3 months
Severe adverse events through day-90 after the onset of acute ischemic stroke.
Time frame: 7 days
National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge. Ranged from 0 to 42, a low value represents a better outcome.
Time frame: 3 months
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: 24 hours
Hematological samples are collected at right before thrombolysis and 24 hours after thrombolysis, and changes of hematological indicators related to hemorrhagic transformation (such as Axl, ANGPTL4) are compared between the two groups.
Time frame: 10 days
The function of patients' dynamic cerebral autoregulation are tested 3 times within 10 days from onset and compared between the two groups.
Yi Yang
Other
Acronym: SERICT-AIS
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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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