to detect the efficiency and safety of intravenous rtPA combined with RIPC in acute ischemic stroke patients
Remote ischemic post-conditioning, which consists of several brief cycles of intermittent ischemia-reperfusion of the arm or leg, may potentially confer a powerful systemic protection against prolonged ischemia in a distant organ. Numerous reports have confirmed it strongest endogenous neuroprotection against brain injury after stroke. Ren et al demonstrated that remote ischemic post-conditioning (RIPC) performed in the hind limbs can not only significantly reduce the stroke volume within 3 hours in rat model, but also ameliorate the outcome of the behavioral test. A long-term repeated RIPC therapy can also help improving neurological functions. A combination of RIPC and tPA can help with neuroprotection which improves the neurological functions. Thus, it is meaningful to transform these basic experimental results to the clinical treatment. In the RECAST-1 trial, RIC has shown it safety and efficiency in AIS patients without tPA. However, there is no further explanation for the patients with IVT. Thus, in this study, we aim to demonstrate the efficiency and safety of RIPC in AIS patients performed rt-PA within 4.5 hours.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
In this study, the remote ischemic conditioning treatment was composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which was induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation.
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGLu He hospital, Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGinfarction volume in brain between two groups
assess by MRI-DWI and ADC
Time frame: measured during 72 h
The score of Modified Rankin scale score
The Modified Rankin Scale Score (mRS) is the most comprehensive and most widely used primary outcome measurement to assess the neurological functional disability in contemporary acute stroke trials. The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranges from 0 (no symptom) to 5 (severe disability) and 6 (death). We will use mRS to evaluate the degree of disability or dependence during daily activities. The mRS will be assessed by certified study investigator, who is blinded to the treatment assignment, at 90 days postoperation. The distribution of mRS will be compared between groups
Time frame: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
proportional of Modified Rankin scale scored 0-1
The Modified Rankin Scale Score (mRS) is the most comprehensive and most widely used primary outcome measurement to assess the neurological functional disability in contemporary acute stroke trials. The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranges from 0 (no symptom) to 5 (severe disability) and 6 (death). We will use mRS to evaluate the degree of disability or dependence during daily activities. The mRS will be assessed by certified study investigator, who is blinded to the treatment assignment, at 90 days postoperation. The distribution of mRS will be compared between groups
Time frame: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
The score of National Institute of Health stroke scale score
National Institute of Health Stroke Scale (NIHSS) is considered as a standardized assessment of neurological functions in the acute phase of stroke, and it is generally used to quantify patient's neurological impairments on 15 items in 11 fields of different neurological status.The score of the scale ranges from 0 to 42.And higher score indicates worse neurological function.
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Time frame: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
The score of Barthel Index(BI)
the BI is used to measure performance in activities of daily living.The score of the scale ranges from 0 to 100. And lower score indicates worse activities of daily living.
Time frame: measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days
recurrence of stroke and TIA
Stroke recurrence was defined as sudden functional deterioration in neurologic status with a decrease of 4 or more in the NIHSS, or a new stroke lesion on MRI/DWI located at the territory of the affected intracranial arteries.
Time frame: changes from baseline(before RIPC) to 90±7 days
death and any other adverse events
The investigator will record the number.
Time frame: changes from baseline(before RIPC) to 90±7 days
any ICH
Head computed tomography or magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.
Time frame: changes from baseline(before RIPC) to 90±7 days
Distal radial pulses
professional doctors will check the distal radial pulses
Time frame: during 90 days
Visual inspection for local edema
Professional oculists will check the fundus oculi to evaluate whether there is local edema.
Time frame: during 90 days
The number of patients with erythema,and/or skin lesions related to RIC
Professional doctors will check it and the investigator will record the number.
Time frame: during 90 days
Palpation for tenderness
Professional doctors will check it.
Time frame: during 90 days
The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
The investigator will record the number.
Time frame: during 90 days
the score of Numeric Rating Scale (NRS)
The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. The score from 0-10. the higher
Time frame: during 90 days
the score of Hamilton Rating Scale for Depression（HAMAD）
this score was used to provide an indication of depression, and as a guide to evaluate recovery.
Time frame: change from baseline(before rtPA) to 90 days
level of MMP-9
Blood samples will be drawn from cubital vein to test these biomarkers.These samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Time frame: measured at baseline(before RIPC,after rtPA) and 7 days
level of IL-6
Blood samples will be drawn from cubital vein to test these biomarkers.These samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Time frame: measured at baseline(before RIPC,after rtPA) and 7 days
level of HS-CRP
Blood samples will be drawn from cubital vein to test these biomarkers.These samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Time frame: measured at baseline(before RIPC,after rtPA) and 7 days
The level of vascular endothelial growth factor
Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Time frame: measured at baseline(before RIPC,after rtPA) and 7 days