Intra-arterial Magnesium Administration for Acute Stroke
Primary Purpose
Acute Stroke
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Magnesium Sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Acute Stroke focused on measuring stroke, Magnesium, endovascular
Eligibility Criteria
Inclusion Criteria:
- Patient with acute cerebral ischemia due to ICA or MCA occlusion,
- Patient's clinical attending physician plans mechanical embolectomy procedure as part of routine clinical care.
- Age 21-95.
Exclusion Criteria:
- Severe renal impairment with creatinine 3.0 or higher,
- Myasthenia gravis,
- Second or third degree heart block without a pacemaker in place,
- Technical inability to navigate microcatheter to target clot,
- Patient already enrolled in another experimental treatment trial. Exclusion criteria 1-3 are all contraindications to magnesium therapy.
Sites / Locations
- University California Los Angeles: Ronald Reagan and Santa Monica Hospitals
- University of Southern California University and LA County Hospitals
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Regional Intra-arterial Magnesium 0.75g
Regional Intra-arterial magnesium 1.5g
Regional/ Distal (75/25%) Magnesium 1.5g
Regional/ Distal (50/50%) Magnesium 1.5g
Arm Description
Regional Intra-arterial magnesium only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients
Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients
Regional/ Distal intra-arterial magnesium (75% TD regional- 1.125g / 25% distal-0.375g): 5 patients
Regional/ Distal intra-arterial magnesium (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients
Outcomes
Primary Outcome Measures
Magnesium Concentration in Region of Cerebral Ischemia
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
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)
Full Information
NCT ID
NCT01502761
First Posted
December 22, 2011
Last Updated
July 26, 2017
Sponsor
University of Southern California
Collaborators
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT01502761
Brief Title
Intra-arterial Magnesium Administration for Acute Stroke
Official Title
Intra-arterial Magnesium Therapy: A Novel Platorm for Neuroprotectant Delivery in Acute Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
No safety issues. Low enrollment secondary to negative stroke studies 2013
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
stroke, Magnesium, endovascular
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regional Intra-arterial Magnesium 0.75g
Arm Type
Experimental
Arm Description
Regional Intra-arterial magnesium only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients
Arm Title
Regional Intra-arterial magnesium 1.5g
Arm Type
Experimental
Arm Description
Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients
Arm Title
Regional/ Distal (75/25%) Magnesium 1.5g
Arm Type
Experimental
Arm Description
Regional/ Distal intra-arterial magnesium (75% TD regional- 1.125g / 25% distal-0.375g): 5 patients
Arm Title
Regional/ Distal (50/50%) Magnesium 1.5g
Arm Type
Experimental
Arm Description
Regional/ Distal intra-arterial magnesium (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
Intra-arterial
Primary Outcome Measure Information:
Title
Magnesium Concentration in Region of Cerebral Ischemia
Description
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.
Time Frame
Mg level: 1) Peripheral: Baseline and post-treatment (averaged); 2) Distal: after first pass of the clot retriever
Secondary Outcome Measure Information:
Title
Number of Participants With Procedure Related Serious Adverse Event
Description
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)
Time Frame
intraprocedure, postoperative day 1, 1 month, 3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with acute cerebral ischemia due to ICA or MCA occlusion,
Patient's clinical attending physician plans mechanical embolectomy procedure as part of routine clinical care.
Age 21-95.
Exclusion Criteria:
Severe renal impairment with creatinine 3.0 or higher,
Myasthenia gravis,
Second or third degree heart block without a pacemaker in place,
Technical inability to navigate microcatheter to target clot,
Patient already enrolled in another experimental treatment trial. Exclusion criteria 1-3 are all contraindications to magnesium therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William J Mack, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey Saver, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University California Los Angeles: Ronald Reagan and Santa Monica Hospitals
City
Los Angeles
State/Province
California
ZIP/Postal Code
900094
Country
United States
Facility Name
University of Southern California University and LA County Hospitals
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Intra-arterial Magnesium Administration for Acute Stroke
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