Endovascular Magnesium Sampling in Acute Stroke

Study Overview
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Brief Summary
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This investigation will address the safety and feasibility of distal, intra-arterial sampling through endovascular access, in acute stroke patients. Levels of Magnesium will be measured in the region of infarct in patients who had been treated with intravenous Magnesium therapy following an acute stroke. This study attempts to address whether the traditional intravenous means of neuroprotectant administration achieves adequate concentration of the therapeutic agent in the area of diseased tissue.

Official Title
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Magnesium Therapy: a Novel Platform for Neuroprotectant Sampling in Acute Stroke

Conditions
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Acute Stroke

Intervention / Treatment
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* Other: endovascular sampling


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 already enrolled in the NIH FAST-MAG clinical trial, Patient's clinical attending physician plans mechanical embolectomy procedure as part of routine clinical care. Age 40-95 inclusive (age criteria for FAST-MAG Trial). Exclusion Criteria: Technical inability to navigate microcatheter to target clot. Patient or surrogate unavailable for consent

Ages Eligible for Study
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Minimum Age: 40 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endovascular Sampling<br>Paired sampling from the distal arterial(endovascular catheter) and peripheral venous (femoral sheath) locations in acute stroke patients undergoing endovascular recanalization who received intravenous Magnesium Sulfate as a part of the FAST-MAG study | Other: endovascular sampling<br>* Paired sampling from the distal arterial(endovascular catheter) and peripheral venous (femoral sheath) locations: withdrawal of 3ml of blood from vasculature distal to the occlusive thrombus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnesium concentration | The primary endpoint is the relative concentration of Mg in the core cerebral ischemic zone, compared to systemic therapeutic Mg levels, as a measure of delivery efficacy of systemic administration. | intra-procedure (at time of first pass of retrieval device) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sampling feasibility | sampling feasibility will be determined by the proportion of cases in which a cerebral circulation Mg level was successfully assayed | intra-procedural (at time of first pass of retrieval device) | 
| Safety | safety will be assessed by intraoperative adverse events, postoperative neurologic examination including NIH stroke scale, and postoperative brain imaging. | post-operative day 1 | 

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