Protective Effects of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction

Study Overview
=================
Brief Summary
-----------------
Stroke is one of the three leading causes of human death, and a major cause of adult disability. Our pre-clinical studies confirmed that ischemic preconditioning can prevent cerebral infarction. Animal studies confirmed that ischemic postconditioning can reduce infarct size of cerebral infarction. Investigators hypothesized that postconditioning would reduce infarct volume of ischemic stroke patients.

Detailed Description
-----------------
This study explored the neuroprotective effects of post-positioning on ischemic stroke patients with randomized, double-blinded and controlled method. Patients are divided into experimental and placebo groups to receive remote ischemic post-conditioning for 30 days. Remote ischemic post-conditioning is performed by the inflating tourniquets to certain extents on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days. It is 200mmHg for RIPC group and 60mmHg for control group. Evaluation parameters include CRP, TNF-α, ICAM-1 and GFAP in blood at 0, 3, 7, 15 and 30 days after treatment; and MRI at 0 and 30 days after treatment.

Official Title
-----------------
Phase 2 Study of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: RIPC group
* Device: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 40 to 80 Years Ischemic cerebrovascular disease within 6 hours National Institutes of Health Stroke Scale(NIHSS) score 0-15,and Modified Rankin Scale(mRS) score 0-4 Cranial CT to rule out the the cerebral hemorrhage Written informed consent was Exclusion Criteria: Cerebral hemorrhage Other parts of the active bleeding disease Atrial fibrillation Moyamoya disease or vasculitis Hereditary disease, such as with CADASIL, FABRY, mitochondrial myopathy Out coagulation disorder Severe lesions of severe liver and kidney disease, malignancy or other systemic Cannot tolerate BLIPC or without informed consent

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIPC group<br>RIPC treatment was performed by the inflating tourniquets to 200mmHg on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days. | Device: RIPC group<br> <br> * Other names: Productor: Beijing Renqiao Institute of Neuroscience;|
| Sham Comparator: Control group<br>RIPC sham was performed by the inflating tourniquets to 60mmHg on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days. | Device: Control group<br> <br> * Other names: Productor: Beijing Renqiao Institute of Neuroscience;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tissue damage 30 days after RIPC treatment | Evaluated by the doctor blinded to the study protocol, including: local edema, redness, skin breakage | 30 days after RIPC treatment | 
| Levels of plasma biomarkers assay right before RIPC treatment | levels of CRP、TINF-α、slCAM-1 and GFAP | right before RIPC treatment (within 24hrs) | 
| Levels of plasma biomarkers assay 3 days after RIPC treatment. | levels of CRP、TINF-α、slCAM-1 and GFAP | 3 days after RIPC treatment. | 
| Levels of plasma biomarkers assay 15 days after RIPC treatment. | levels of CRP、TINF-α、slCAM-1 and GFAP | 15 days after RIPC treatment. | 
| Levels of plasma biomarkers assay 30 days after RIPC treatment | levels of CRP、TINF-α、slCAM-1 and GFAP | 30 days after RIPC treatment | 
| Levels of plasma biomarkers assay right after RIPC treatment | levels of CRP、TINF-α、slCAM-1 and GFAP | right after RIPC treatment (within 24hrs) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct volume evaluation before RIPC treatment. | MRI evaluation of infarct volume in ischemic stroke patients before RIPC treatment. | Acute phase of ischemic stroke, and before RIPC treatment | 
| Infarct volume after RIPC treatment in ischemic stroke patients | Infarct volume evaluation in ischemic stroke patients after 30 RIPC treatment | 30 days after RIPC treatment in ischemic stroke patients |