Intra-arterial Magnesium Administration for Acute Stroke

This study is ongoing, but not recruiting participants.
University of California, Los Angeles
Information provided by (Responsible Party):
William Mack, University of Southern California Identifier:
First received: December 22, 2011
Last updated: May 26, 2015
Last verified: May 2015
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

Condition Intervention Phase
Acute Stroke
Drug: Magnesium Sulfate
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intra-arterial Magnesium Therapy: A Novel Platorm for Neuroprotectant Delivery in Acute Stroke

Resource links provided by NLM:

Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Magnesium concentration in region of cerebral ischemia [ Time Frame: following fist pass of the clot retriever (average 1 minute after Mg administration) ] [ Designated as safety issue: No ]
    Systemic Magnesium levels will be obtained through the femoral sheath at the beginning (baseline) and end (post-treatment) of each case. Magnesium levels distal to the occlusion will be measured at the first pass of the clot retrieving device.

Secondary Outcome Measures:
  • Procedure related serious adverse event [ Time Frame: intraprocedure, postoperative day 1, 1 month, 3 month ] [ Designated as safety issue: Yes ]
    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)

Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regional Intra-arterial Magnesium 0.75g
Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients
Drug: Magnesium Sulfate
Experimental: Regional Intra-arterial magnesium 1.5g
Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients
Drug: Magnesium Sulfate
Experimental: Regional/ Distal (75/25%) Magnesium 1.5g
Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients
Drug: Magnesium Sulfate
Experimental: Regional/ Distal (50/50%) Magnesium 1.5g
Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients
Drug: Magnesium Sulfate


Ages Eligible for Study:   21 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01502761

United States, California
University California Los Angeles: Ronald Reagan and Santa Monica Hospitals
Los Angeles, California, United States, 900094
University of Southern California University and LA County Hospitals
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
University of California, Los Angeles
Principal Investigator: William J Mack, MD University of Southern California
Principal Investigator: Jeffrey Saver, MD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: William Mack, Assistant Professor of Neurosurgery, University of Southern California Identifier: NCT01502761     History of Changes
Other Study ID Numbers: HS-11-00339
Study First Received: December 22, 2011
Last Updated: May 26, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Southern California:

Additional relevant MeSH terms:
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Magnesium Sulfate
Anti-Arrhythmia Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Tocolytic Agents processed this record on November 27, 2015