Intra-arterial Magnesium Administration for Acute Stroke

Study Overview
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Brief Summary
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Stroke is the second leading cause of death and the leading cause of adult disability worldwide. This investigation will address the safety and feasibility of directed, intra-arterial Magnesium measurement and therapy, through endovascular access, in acute stroke patients. The proposal represents the first study to directly quantify levels of a systemically administered neuroprotectant in the region of cerebral ischemia. It also establishes a novel endovascular platform for direct delivery of neuroprotective agents to ischemic cerebral tissue distal to an occlusive thrombus. This research seeks to improve patient care by establishing a novel delivery mechanism for the rescue of threatened brain parenchyma that can be administered rapidly following acute stroke. If successful, this selective distribution will allow delivery to at risk tissue in a rapid manner. Salvage of viable, but threatened, penumbral tissue could afford stroke patients an increased probability of favorable long term outcome. The investigators hypothesize that endovascular, intra-arterial, Magnesium administration will deliver high concentration of this neuroprotective agent to otherwise inaccessible cerebral territories, while limiting systemic concentrations. The proposed investigation will evaluate the safety and feasibility of this novel treatment technique

Official Title
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Intra-arterial Magnesium Therapy: A Novel Platorm for Neuroprotectant Delivery in Acute Stroke

Conditions
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Acute Stroke

Intervention / Treatment
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* Drug: Magnesium Sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with acute cerebral ischemia due to ICA or MCA occlusion, Patient's clinical attending physician plans mechanical embolectomy procedure as part of routine clinical care. Age 21-95. Exclusion Criteria: Severe renal impairment with creatinine 3.0 or higher, Myasthenia gravis, Second or third degree heart block without a pacemaker in place, Technical inability to navigate microcatheter to target clot, Patient already enrolled in another experimental treatment trial. Exclusion criteria 1-3 are all contraindications to magnesium therapy.

Ages Eligible for Study
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Minimum Age: 21 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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regional Intra-arterial Magnesium 0.75g<br>Regional Intra-arterial magnesium only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients | Drug: Magnesium Sulfate<br>* Intra-arterial<br>|
| Experimental: Regional Intra-arterial magnesium 1.5g<br>Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients | Drug: Magnesium Sulfate<br>* Intra-arterial<br>|
| Experimental: Regional/ Distal (75/25%) Magnesium 1.5g<br>Regional/ Distal intra-arterial magnesium (75% TD regional- 1.125g / 25% distal-0.375g): 5 patients | Drug: Magnesium Sulfate<br>* Intra-arterial<br>|
| Experimental: Regional/ Distal (50/50%) Magnesium 1.5g<br>Regional/ Distal intra-arterial magnesium (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients | Drug: Magnesium Sulfate<br>* Intra-arterial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnesium Concentration in Region of Cerebral Ischemia | Peripheral Magnesium Levels, meq/L will be obtained through the femoral sheath at the beginning (baseline) and end (post-treatment) of each case. These will be averaged to obtain a femoral Magnesium level. Magnesium levels distal to the occlusion will be measured at the first pass of the clot retrieving device. | Mg level: 1) Peripheral: Baseline and post-treatment (averaged); 2) Distal: after first pass of the clot retriever | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Procedure Related Serious Adverse Event | Periprocedural clinical, radiographic and laboratory data will be collected and analyzed to detect Mg related adverse events. Outcome will be assessed perioperatively and at 24 hours, 30 days (+/- 10 days) and 90 days (+/- 15 days) | intraprocedure, postoperative day 1, 1 month, 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, Magnesium, endovascular