Intra-arterial Magnesium Administration for Acute Stroke

NCT01502761 | Terminated Phase 1 Results DMC

• 1 other identifier: HS-11-00339
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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

Conditions

Acute Stroke

Keywords

stroke; Magnesium; endovascular

Outcome Measures

Primary Outcomes (1)

• 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.

  Mg level: 1) Peripheral: Baseline and post-treatment (averaged); 2) Distal: after first pass of the clot retriever

Secondary Outcomes (1)

• Number of Participants With Procedure Related Serious Adverse Event

  intraprocedure, postoperative day 1, 1 month, 3 month

Study Arms (4)

Regional Intra-arterial Magnesium 0.75g

EXPERIMENTAL

Regional Intra-arterial magnesium only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients

Drug: Magnesium Sulfate

Regional Intra-arterial magnesium 1.5g

EXPERIMENTAL

Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients

Drug: Magnesium Sulfate

Regional/ Distal (75/25%) Magnesium 1.5g

EXPERIMENTAL

Regional/ Distal intra-arterial magnesium (75% TD regional- 1.125g / 25% distal-0.375g): 5 patients

Drug: Magnesium Sulfate

Regional/ Distal (50/50%) Magnesium 1.5g

EXPERIMENTAL

Regional/ Distal intra-arterial magnesium (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients

Drug: Magnesium Sulfate

Interventions

Magnesium Sulfate DRUG

Intra-arterial

Regional Intra-arterial Magnesium 0.75g; Regional Intra-arterial magnesium 1.5g; Regional/ Distal (50/50%) Magnesium 1.5g; Regional/ Distal (75/25%) Magnesium 1.5g

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• University of Southern California: lead
• University of California, Los Angeles: collaborator

Study Sites (2)

University California Los Angeles: Ronald Reagan and Santa Monica Hospitals

Los Angeles, California, 900094, United States

Location

University of Southern California University and LA County Hospitals

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Limitations and Caveats

The trial was terminated early (with enrollment only in the first arm) by the investigators due to low enrollment (given results of relevant studies at the time) . There were no safety concerns with the trial or the agent.

Results Point of Contact

• Title: Dr. William J Mack
• Organization: University of Southern California

william.mack@med.usc.edu

323 442 7512

Study Officials

• William J Mack, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Jeffrey Saver, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurosurgery

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: January 2, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 28, 2017
• Results First Posted: August 28, 2017

Record last verified: 2017-07

Locations

US (2)