Intra-arterial Magnesium Administration for Acute Stroke

This study is currently recruiting participants.
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

December 22, 2011
February 16, 2013
March 2012
December 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01502761 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
Intra-arterial Magnesium Administration for Acute Stroke
Intra-arterial Magnesium Therapy: A Novel Platorm for Neuroprotectant Delivery in Acute Stroke

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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Stroke
Drug: Magnesium Sulfate
Intra-arterial
  • Experimental: Regional Intra-arterial Magnesium 0.75g
    Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients
    Intervention: Drug: Magnesium Sulfate
  • Experimental: Regional Intra-arterial magnesium 1.5g
    Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients
    Intervention: Drug: Magnesium Sulfate
  • Experimental: Regional/ Distal (75/25%) Magnesium 1.5g
    Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients
    Intervention: Drug: Magnesium Sulfate
  • Experimental: Regional/ Distal (50/50%) Magnesium 1.5g
    Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients
    Intervention: Drug: Magnesium Sulfate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
March 2014
December 2013   (final data collection date for primary outcome measure)

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.
Both
21 Years to 95 Years
No
Contact: William J Mack, MD 323-226-7421 mackw@usc.edu
United States
 
NCT01502761
HS-11-00339
Yes
William Mack, University of Southern California
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
University of Southern California
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP