Intra-arterial Magnesium Administration for Acute Stroke

Acute Stroke Clinical Trial

Official title:

Intra-arterial Magnesium Therapy: A Novel Platorm for Neuroprotectant Delivery in Acute Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01502761
• Other study ID #: HS-11-00339
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 22, 2011
• Last updated: May 27, 2016
• Start date: March 2012
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 95 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Drug:
• Magnesium Sulfate
Intra-arterial

Locations

Country	Name	City	State
United States	University California Los Angeles: Ronald Reagan and Santa Monica Hospitals	Los Angeles	California
United States	University of Southern California University and LA County Hospitals	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnesium concentration in region of cerebral ischemia	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.	following fist pass of the clot retriever (average 1 minute after Mg administration)	No
Secondary	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)	intraprocedure, postoperative day 1, 1 month, 3 month	Yes