The Neuroprotective Effect of Remote Ischemic Preconditioning on Ischemic Cerebral Vascular Disease

Study Overview
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Brief Summary
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This study is a prospective, randomized, single-center trial, designed to observe the effect of remote limb ischemic preconditioning on ischemic cerebral vascular disease.

Conditions
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Cerebrovascular Disease

Intervention / Treatment
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* Procedure: Remote ischemic preconditioning (RIPC)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients with stroke or transient ischemic attack (TIA) within 180 days and the neurologic deficits were well matched to the territory of the stenosed artery, with intracranial arterial stenosis of at least 50% by angiography, at least 70% by ultrasound, or at least 70% by computed tomographic angiography (CTA) or magnetic resonance angiography (MRA) Age between 18 to 80 years old Trial of Org 10172 in Acute Stroke Treatment-1 (TOAST-1) subtype National Institutes of Health Stroke Scale (NIHSS) score 0-15, and Modified Rankin Scale (mRS) score 0-4. ABCD2 score between 6 to 7 Stable vital signs, normal hepatic and renal functions, No hemorrhagic tendencies. Exclusion criteria: Within 72 hrs of intra-artery or intravenous thrombolysis Intracranial hemorrhage or large area of cerebral infarction (more than 1/3 middle cerebral artery perfusion territory) Any soft tissue, orthopedic, or vascular injury, wounds or fractures in extremities which may pose a contraindication for application of the preconditioning cuffs Acute myocardial infarction Systolic blood pressure more than 200 mmHg after drug control Peripheral blood vessel disease Hematologic disease Severe hepatic and renal dysfunction Severe or unstable concomitant disease Cannot tolerate BLIPC or without informed consent Patients who did not complete the whole treatment procedure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIPC+stroke secondary prevension<br>Procedure/Surgery: Remote Ischemic Preconditioning (RIPC) The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day. Procedure:stroke secondary prevention(Such as Antiplatelet therapy, Cholesterol-lowering therapymaintain blood pressure and blood sugar normal) | Procedure: Remote ischemic preconditioning (RIPC)<br>* The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.<br>|
| No Intervention: stroke secondary prevention<br>Procedure:stroke secondary prevention(Such as Antiplatelet therapy, Cholesterol-lowering therapymaintain blood pressure and blood sugar normal) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure and Heart Rates; |  | at the time points of baseline and 1, 15 and 30 days after BLIPC treatment | 
| Plasma Biomarkers of Coagulation and Fibrinolysis | blood samples were collected one hour after every times of BLIPC procedure ended, and assayed with the immuno-turbidimetry assay on the coagulation laboratory autoanalyzer | the time points of baseline and 1, 15 and 30 days after BLIPC treatment | 
| Number of Patients Who Got New Brain Lesions | We compared the number of patients who got new lesions in the Diffusion-weighted magnetic resonance imaging (DWI-MRI) | 300 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Time Point Until the First Stroke Recurrence, | These patients underwent MRI/DWI at the time of first recurrence; patients without symptoms recurrence underwent follow-up MRI/DWI at 300 days. | At the 300-day after the initial treatment | 
| Brain Perfusion Improvement Are Evaluated With SPECT and TCD | Brain perfusion status were evalvated by SPECT SPECT scanning was performed using a dual headed rotating gamma camera at 30 minutes after intravenous 99mTc-ECD (25mCi) bolus injection and at 40 minutes after 18F -FDG bolus injection. | 300-day after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic cerebral vascular disease, stroke secondary prevention, remote ischemic preconditioning