Feasibility, Safety and Efficacy of Remote Ischemic Preconditioning for Symptomatic Intracranial Arterial Stenosis in Octogenarians

Study Overview
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Brief Summary
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Making a limb transiently ischemic induces ischemic tolerance in distant organs such as the heart. This study aims to evaluate the feasibility, safety and initial efficacy of using briefly repetitive bilateral limb ischemic preconditioning (BLIPC) to protect the brain in octogenarians with symptomatic intracranial arterial stenosis.

Official Title
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Feasibility, Safety and Efficacy of RIPC for Symptomatic Intracranial Arterial Stenosis in Octogenarians

Conditions
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Bilateral Limb Ischemic Preconditioning, Intracranial Arterial Stenosis

Intervention / Treatment
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* Device: bilateral limb ischemic preconditioning (Doctormate, IPC-906X)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 80 to 95 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

Ages Eligible for Study
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Minimum Age: 80 Years
Maximum Age: 95 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: bilateral limb ischemic preconditioning (BLIPC)<br>5 minutes bilateral limb ischemic preconditioning treatment with an inflating tourniquets to 200 mmHg | Device: bilateral limb ischemic preconditioning (Doctormate, IPC-906X)<br>* Device: bilateral limb ischemic preconditioning (Doctormate, IPC-906X, produced by Beijing Renqiao Institute of Neuroscience)five cycles of 5 minutes bilateral upper limb ischemia-reperfusion performed by inflating tourniquets to 200 mmHg, twice daily for 180 consecutive days, along with conventional medical treatment.<br>|
| No Intervention: Control group<br>underwent equivalent medical treatments only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective signs of tissue or neurovascular injury | objective signs of tissue or neurovascular injury felt to be due to cuff inflation, which was based on the judgment of the observers (blinded to study protocol) precluded continuation. Inspection included palpation of distal radial pulses, visual inspection (for local edema, redness, skin breakdown), and palpation for tenderness | 180 days after treatment | 
| levels of plasma biomarkers | levels of plasma myoglobin at baseline and at the 1st, 15th and 30th day during BLIPC treatment were monitored | 180-day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remote ischemic preconditioning, octogenarian, intracranial arterial stenosis, stroke recurrence