An interventional study of Remote ischemic conditioning and Sham remote ischemic conditioning in Acute Ischemic Stroke, sponsored by Yi Yang. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-02.
Sponsored by Yi Yang · Not applicable, Interventional, and Treatment
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.
2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.
This study's planned enrollment of 2,210 is above the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.
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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. RIC will be conducted twice daily for 7 consecutive days. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014.
Procedure: Remote ischemic conditioning
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. RIC will be conducted twice daily for 7 consecutive days. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014.
Procedure: Sham remote ischemic conditioning
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.
Proportion 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
Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days.
Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days.
Time frame: 24 hours, 7 days, 30±3 days, 90±3 days
heart rate at 24 hours, 7 days, 30±3 days, 90±3 days.
heart rate at 24 hours, 7 days, 30±3 days, 90±3 days.
Time frame: 24 hours, 7 days, 30±3 days, 90±3 days
Numeric rating scales (NRS) score during intervention.
Numeric rating scales (NRS) score during intervention. Ranged from 0 to 10, a low value represents a less pain.
Time frame: 7 days
Proportion of patients with early withdrawal for safety or tolerability reasons.
Proportion of patients with early withdrawal for safety or tolerability reasons.
Time frame: 7 days
This study is status unknown, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Yi Yang