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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
December 22, 2011
January 2, 2012
June 30, 2017
August 28, 2017
August 28, 2017
March 2012
May 2016   (Final data collection date for primary outcome measure)
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.
Magnesium Concentration in Region of Cerebral Ischemia [ Time Frame: following fist pass of the clot retriever (average 1 minute after Mg administration) ]
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.
Complete list of historical versions of study NCT01502761 on ClinicalTrials.gov Archive Site
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)
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)
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Stroke
Drug: Magnesium Sulfate
Intra-arterial
  • Experimental: Regional Intra-arterial Magnesium 0.75g
    Regional Intra-arterial magnesium 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 intra-arterial magnesium (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 intra-arterial magnesium (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.
 
Terminated
4
May 2016
May 2016   (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.
Sexes Eligible for Study: All
21 Years to 95 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01502761
HS-11-00339
Yes
Not Provided
Not Provided
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
July 2017

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