Intra-arterial Magnesium Administration for Acute Stroke

University of Southern California

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Acute Stroke

Treatments: Drug: Magnesium Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT01502761

HS-11-00339

Details and patient eligibility

About

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

Enrollment: 4 patients

Sex: All

Ages: 21 to 95 years old

Volunteers: No Healthy Volunteers

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,
5. Patient already enrolled in another experimental treatment trial. Exclusion criteria 1-3 are all contraindications to magnesium therapy.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 4 patient groups

Regional Intra-arterial Magnesium 0.75g

Experimental group

Description:

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

Treatment:

Drug: Magnesium Sulfate

Regional Intra-arterial magnesium 1.5g

Experimental group

Description:

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

Treatment:

Drug: Magnesium Sulfate

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

Experimental group

Description:

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

Treatment:

Drug: Magnesium Sulfate

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

Experimental group

Description:

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

Treatment:

Drug: Magnesium Sulfate