The primary objective of the study will be to determine whether remote limb ischemic conditioning (RLIC) together with conventional medication therapy compared with only medication therapy reduces the 3-month risk of composite cardio-cerebral vascular event in patients with a recent TIA or IS caused by occlusion of a cerebral artery. After screening period, eligible patients will be randomly allocated into 2 groups.In addition, all participants receive an usual clinical therapy.
In this study, Patients in the RLIC group will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) twice daily and conventional medication; patients in the control group will be treated only with conventional medication. In the study, the RLIC treatment will be comprised of 5 cycles of bilateral upper limb ischemia and reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and inflated to 200mmHg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
700
Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) twice daily and conventional medication for 3 months.
Patients will be treated with conventional medication for 3 months.
3-month composite cardio-cerebral vascular event rate
Time frame: During the first 3 months from randomization.
Recurrence of TIA or infarction rate in the area of responsible vessel domination within 3 months
Time frame: During the first 3 months from randomization.
Changes in National Institutes of Health Stroke Scale(NIHSS) within 3 months
Time frame: During the first 3 months from randomization.
Changes in modified Rankin Scale(mRS) within 3 months
Time frame: During the first 3 months from randomization.
Changes in Barthel Index(BI) within 3 months
Time frame: During the first 3 months from randomization.
12-month composite cardio-cerebral vascular event rate
Time frame: During the first 12 months from randomization.
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