Safety and Efficacy Study of Remote Ischemic Conditioning Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation
- Conditions
- Acute Ischemic Stroke
- Interventions
- Procedure: Remote ischemic conditioningProcedure: Sham remote ischemic conditioning
- Registration Number
- NCT04977869
- Lead Sponsor
- Yi Yang
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 498
-
- Age ≥ 18 years, male or female
-
- Diagnosis of acute ischemic stroke within 24 hours of symptom onset and underwent endovascular thrombectomy (EVT) adhering to current guidelines for large vessel occlusion in the anterior circulation (confirmed by computed tomography angiography or digital subtraction angiography)
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- Pre-EVT NIHSS ≥ 6
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- Premorbid mRS ≤ 2
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- Written informed consent obtained from the patient or legally responsible person
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- Contraindication of endovascular thrombectomy
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- Contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture, or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, and subclavian steal syndrome
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- Head CT showing cerebral hernia and midline displacement
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- Pregnancy or lactation
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- Previous remote ischemic conditioning therapy or similar treatment
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- Severe hepatic and renal dysfunction
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- Life expectancy of less than 3 months or inability to complete the study for other reasons
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- Unwilling to be followed up or poor compliance
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- Current or past participation in other clinical research, or participation in this study within 3 months prior to admission
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- Other conditions that the researchers think make the patient unsuitable for the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RIC+Standard medical treatment Remote ischemic conditioning RIC+Standard medical treatment 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 days after endovascular thrombectomy. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2018. Sham RIC+Standard medical treatment Sham remote ischemic conditioning Sham RIC+Standard medical treatment 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 days after endovascular thrombectomy. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2018.
- Primary Outcome Measures
Name Time Method Proportion of patients with modified Rankin Scale (mRS) Score 0-2 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.
- Secondary Outcome Measures
Name Time Method Frequency of Hemorrhagic transformation within 7 days 7 days Frequency of Hemorrhagic transformation within 7 days
Frequency of symptomatic intracranial hemorrhage within 7 days 7 days Frequency of symptomatic intracranial hemorrhage within 7 days
Death within 90 days 90±3 days Death within 90 days
Frequency of adverse events within 90 days 90±3 days Frequency of adverse events within 90 days
National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days (or discharge) after EVT. 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.
Barthel Index (BI) at 24 hours, 7 days (or discharge) after EVT. 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.
Proportion of patients with modified Rankin Scale (mRS) 0-1 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.
modified Rankin Scale (mRS) score distribution 90±3 days modified Rankin Scale (mRS) score distribution
Recanalization rate within 7 days after EVT 7 days Recanalization rate within 7 days after EVT
Early neurological deterioration at 7 days 7 days Early neurological deterioration at 7 days
Adverse events associated with remote ischemic conditioning within 90 days 90±3 days Adverse events associated with remote ischemic conditioning within 90 days
Frequency of serious adverse events within 90 days 90±3 days Frequency of serious adverse events within 90 days
Trial Locations
- Locations (1)
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China