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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Intra-arterial
University California Los Angeles: Ronald Reagan and Santa Monica Hospitals
Los Angeles, California, United States
University of Southern California University and LA County Hospitals
Los Angeles, California, United States
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.
Time frame: Mg level: 1) Peripheral: Baseline and post-treatment (averaged); 2) Distal: after first pass of the clot retriever
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)
Time frame: intraprocedure, postoperative day 1, 1 month, 3 month
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