Intra-arterial Magnesium Administration for Acute Stroke

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-05-31

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

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Detailed Description

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Conditions

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Acute Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Regional Intra-arterial Magnesium 0.75g

Regional Intra-arterial magnesium only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type DRUG

Intra-arterial

Regional Intra-arterial magnesium 1.5g

Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type DRUG

Intra-arterial

Regional/ Distal (75/25%) Magnesium 1.5g

Regional/ Distal intra-arterial magnesium (75% TD regional- 1.125g / 25% distal-0.375g): 5 patients

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type DRUG

Intra-arterial

Regional/ Distal (50/50%) Magnesium 1.5g

Regional/ Distal intra-arterial magnesium (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type DRUG

Intra-arterial

Interventions

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Magnesium Sulfate

Intra-arterial

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patient with acute cerebral ischemia due to ICA or MCA occlusion,
2. Patient's clinical attending physician plans mechanical embolectomy procedure as part of routine clinical care.
3. Age 21-95.

Exclusion Criteria

1. Severe renal impairment with creatinine 3.0 or higher,
2. Myasthenia gravis,
3. Second or third degree heart block without a pacemaker in place,
4. Technical inability to navigate microcatheter to target clot,

Minimum Eligible Age

21 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No