The First Hospital of Jilin University
Changchun, Jilin, 130000, China
NCT Number: NCT04977869
The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Changchun, Jilin, 130000, China
In this study, 498 cases of ischemic stroke who undergo endovascular thrombectomy within 24 hours from the onset are 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 for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.
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 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.
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, 7 days (or discharge)
National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days (or discharge) after EVT. Ranged from 0 to 42, a low value represents a better outcome.
Time frame: 24 hours, 7 days (or discharge)
Barthel Index (BI) at 24 hours, 7 days (or discharge) after EVT. 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) 0-1. Ranged from 0 to 6, a low value represents a better outcome.
Time frame: 90±3 days
modified Rankin Scale (mRS) score distribution
Time frame: 7 days
Recanalization rate within 7 days after EVT
Time frame: 7 days
Early neurological deterioration at 7 days
Time frame: 7 days
Frequency of Hemorrhagic transformation within 7 days
Time frame: 7 days
Frequency of symptomatic intracranial hemorrhage within 7 days
Time frame: 90±3 days
Death within 90 days
Time frame: 90±3 days
Frequency of adverse events within 90 days
Time frame: 90±3 days
Adverse events associated with remote ischemic conditioning within 90 days
Time frame: 90±3 days
Frequency of serious adverse events within 90 days
Yi Yang
Other
Safety and Efficacy Study of Remote Ischemic Conditioning Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation: 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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