Effects of Limb Ischemic Postconditioning in Young sICAS

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the protective effects of upper limb ischemic postconditioning on collateral circulationin young symptomatic intracranial atherosclerosis and the baseline characteristics of trial participants, as an open, randomized controlled, prospective controlled trial.

Detailed Description
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Stroke is a common cardia-cerebrovascular disease with high morbidity, disability and mortality rate. And more and more young patients account for the increasing morbidity. Among them, Symptomatic intracranial atherosclerotic stenosis（sICAS）is a major cause, especially in Asians. Currently, traditional therapeutic methods present reluctant achievements on reducing stroke recurrence and pose threat on patients'health because of invasive operation and severe side effects. Therefore, other treatment methods are called for urgently. Remote ischemic post-conditioning refers to local or distal ischemia treatment after the occurrence of cerebral ischemia. Prior research has shown that repeatedly ischemic reperfusion have protective effect on lowering the occurrence rate of ischemic events of patients with carotid stenosis. However, in-depth research on cerebral protection and correlation with collateral circulation has not been proven in an open, definitive clinical trial. Thus, the EPIC-sICAS trial will provide important information on the protective effects of upper limb ischemic post-conditioning on collateral circulation after cerebral Infarction. Hopefully to present us a very meaningful way to improve the patient's quality of life.

Official Title
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Effects of Upper Limb Ischemic Postconditioning on Collateral Circulation in Young Symptomatic Intracranial Atherosclerosis

Conditions
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Stroke

Intervention / Treatment
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* Device: Remote ischemic postconditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 to 45 Years old; Symptomatic intracranial atherosclerotic stenosis (sICAS): cranial CTA/MRA/TCD/DSA confirm the diagnosis, patients got ischemic stroke or transient ischemic attack in the brain region supplied by the stenosis artery; National Institutes of Health Stroke Scale(NIHSS) score 0-15 Written informed consent was signed. Exclusion Criteria: Cerebral hemorrhage and other parts of the active bleeding disease; Severe aphasia, unable to express himself; A history of brain tumor, brain trauma, cerebral embolism or other brain lesions; Severe lesions of severe cardiac, liver or kidney disease, malignancy or other systemic organ dysfunction; Blood Pressure< 90 mmHg/60 mmHg or >200 mmHg/110 mmHg after treatment; Dementia and mental illness; Using angiotensin-converting enzyme inhibitors; A history of major surgery or trauma 4 weeks prior to admission; Without informed consent. Elimination Criteria： Patients with poor compliance，refuse to take regular treatment and examination; patients' condition get exacerbated, with NIHSS score elevate for more than 4.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote Ischemic Postconditioning<br>remote ischemic postconditioning（RIPC） treatment was performed by the inflating a cuff around bilateral arms to 180 mmHg with 5 cycles of 3 min inflation and 5 min relax alternation twice a day for the total of 180 consecutive days. | Device: Remote ischemic postconditioning<br>* Remote ischemic postconditioning（RIPC）treatment was performed by the inflating a cuff around bilateral arms to 180 mmHg with 5 cycles of 3 min inflation and 5 min relax alternation automatically.<br>* Other names: limb ischemic postconditioning;|
| No Intervention: Control<br>Patients in control group will receive foundation treatment. Foundation treatment: including blood vessel expansion、free radical elimination etc during acute phase and aspirin (100-300 mg/d), and atorvastatin (20 mg/d) till the end of the study (180 consecutive days). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change of Collateral Circulation from Baseline and at 6 months | Collateral circulation measured in iconography test: Magnetic Resonance Angiography (MRA)、 Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI)、Arterial spin-labeled (ASL) perfusion magnetic resonance、Transcranial Cerebral Doppler (TCD)、single photon emission computed tomography（SPECT） Baseline was defined as the onset of stroke within 48h. A higher score represents better collateral circulation status functioning. | Baseline and at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change of Symptomatic Recovery | Functional test: National Institute of Health stroke scale（NIHSS）scores、Activity of Daily Living Scale (ADL) For NIHSS scores, a lower score represents better functioning. For ADL scores, a higher score represents better functioning. | Baseline and at 14 days, 1 month, 6 months, and 1 year | 
| Mean Change of serum vascular endothelial growth factor (VEGF) and basic Fibroblast Growth Factor (bFGF) from Baseline and at 10 days. | A higher amount represents a better outcome | Baseline and at 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, Remote ischemic postconditioning, symptomatic atherosclerotic intracranial arterial stenosis