Intra-arterial Magnesium Administration for Acute Stroke

Completed

Phase 1/2 Results N/A

Trial Description

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

Conditions

Interventions

  • Magnesium sulfate Drug
    Other Names: Epsom salt; Magnesium sulphate
    Intervention Desc: Intra-arterial
    ARM 1: Kind: Experimental
    Label: Regional Intra-arterial Magnesium 0.75g
    Description: Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients
    ARM 2: Kind: Experimental
    Label: Regional Intra-arterial magnesium 1.5g
    Description: Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients
    ARM 3: Kind: Experimental
    Label: Regional/ Distal (75/25%) Magnesium 1.5g
    Description: Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients
    ARM 4: Kind: Experimental
    Label: Regional/ Distal (50/50%) Magnesium 1.5g
    Description: Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Magnesium concentration in region of cerebral ischemia following fist pass of the clot retriever (average 1 minute after Mg administration) No
Secondary Procedure related serious adverse event intraprocedure, postoperative day 1, 1 month, 3 month Yes

Sponsors