Clinical trial NCT01502761: 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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Acute Stroke
Keywords: stroke
Magnesium
endovascular
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2012-01-02
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Magnesium Concentration in Region of Cerebral Ischemia
timeFrame: Mg level: 1) Peripheral: Baseline and post-treatment (averaged); 2) Distal: after first pass of the clot retriever
Secondary outcomes:
measure: Number of Participants With Procedure Related Serious Adverse Event
timeFrame: intraprocedure, postoperative day 1, 1 month, 3 month
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University California Los Angeles: Ronald Reagan and Santa Monica Hospitals
state: California
city: Los Angeles
country: United States
facility: University of Southern California University and LA County Hospitals
state: California
Study officials:
affiliation: University of Southern California
name: William J Mack, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Jeffrey Saver, MD
role: PRINCIPAL_INVESTIGATOR
References: