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Intra-arterial Magnesium Administration for Acute Stroke

This study has been terminated.
(No safety issues. Low enrollment secondary to negative stroke studies 2013)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01502761
First Posted: January 2, 2012
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
William Mack, University of Southern California
  Purpose
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
Intervention Model: Single Group Assignment
Masking: None (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 William Mack, University of Southern California:

Primary Outcome Measures:
  • Magnesium Concentration in Region of Cerebral Ischemia [ Time Frame: Mg level: 1) Peripheral: Baseline and post-treatment (averaged); 2) Distal: after first pass of the clot retriever ]
    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.


Secondary Outcome Measures:
  • Number of Participants With Procedure Related Serious Adverse Event [ Time Frame: intraprocedure, postoperative day 1, 1 month, 3 month ]
    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)


Enrollment: 4
Study Start Date: March 2012
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regional Intra-arterial Magnesium 0.75g
Regional Intra-arterial magnesium only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients
Drug: Magnesium Sulfate
Intra-arterial
Experimental: Regional Intra-arterial magnesium 1.5g
Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients
Drug: Magnesium Sulfate
Intra-arterial
Experimental: Regional/ Distal (75/25%) Magnesium 1.5g
Regional/ Distal intra-arterial magnesium (75% TD regional- 1.125g / 25% distal-0.375g): 5 patients
Drug: Magnesium Sulfate
Intra-arterial
Experimental: Regional/ Distal (50/50%) Magnesium 1.5g
Regional/ Distal intra-arterial magnesium (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients
Drug: Magnesium Sulfate
Intra-arterial

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01502761


Locations
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
Investigators
Principal Investigator: William J Mack, MD University of Southern California
Principal Investigator: Jeffrey Saver, MD University of California, Los Angeles
  More Information

Responsible Party: William Mack, Assistant Professor of Neurosurgery, University of Southern California
ClinicalTrials.gov Identifier: NCT01502761     History of Changes
Other Study ID Numbers: HS-11-00339
First Submitted: December 22, 2011
First Posted: January 2, 2012
Results First Submitted: June 30, 2017
Results First Posted: August 28, 2017
Last Update Posted: August 28, 2017
Last Verified: July 2017

Keywords provided by William Mack, University of Southern California:
stroke
Magnesium
endovascular

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents