Intra-arterial Magnesium Administration for Acute Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Southern California
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
William Mack, University of Southern California
ClinicalTrials.gov Identifier:
NCT01502761
First received: December 22, 2011
Last updated: February 16, 2013
Last verified: February 2013
  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
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: March 2014
Estimated Primary Completion Date: December 2013 (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
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(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 (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients
Drug: Magnesium Sulfate
Intra-arterial

  Eligibility

Ages Eligible for Study:   21 Years to 95 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01502761

Contacts
Contact: William J Mack, MD 323-226-7421 mackw@usc.edu

Locations
United States, California
University of Southern California University and LA County Hospitals Recruiting
Los Angeles, California, United States, 90033
Contact: William J Mack, MD    323-226-7421    mackw@usc.edu   
Principal Investigator: William J Mack, MD         
Sub-Investigator: Arun P Amar, MD         
Sub-Investigator: Donald W Larsen, MD         
Sub-Investigator: Nerses Sanossian, MD         
Sub-Investigator: Benjamin A Emanuel, DO         
Sub-Investigator: May A Kim, MD         
Sub-Investigator: Gene Y Sung, MD, MPH         
University California Los Angeles: Ronald Reagan and Santa Monica Hospitals Recruiting
Los Angeles, California, United States, 900094
Contact: Jeffrey Saver         
Principal Investigator: Jeffrey Saver, MD         
Sub-Investigator: Gary Duckwiler, MD         
Sub-Investigator: Reza Jahan, MD         
Sub-Investigator: Fernando Vinuela, MD         
Sub-Investigator: Nestor R Gonzalez, MD         
Sub-Investigator: Satoshi Tateshima, MD         
Principal Investigator: David Liebeskind, MD         
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

No publications provided

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
Study First Received: December 22, 2011
Last Updated: February 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Southern California:
stroke
Magnesium
endovascular

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

ClinicalTrials.gov processed this record on August 21, 2014