Endovascular Magnesium Sampling in Acute Stroke
This investigation will address the safety and feasibility of distal, intra-arterial sampling through endovascular access, in acute stroke patients. Levels of Magnesium will be measured in the region of infarct in patients who had been treated with intravenous Magnesium therapy following an acute stroke. This study attempts to address whether the traditional intravenous means of neuroprotectant administration achieves adequate concentration of the therapeutic agent in the area of diseased tissue.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Magnesium Therapy: a Novel Platform for Neuroprotectant Sampling in Acute Stroke|
- Magnesium concentration [ Time Frame: intra-procedure (at time of first pass of retrieval device) ] [ Designated as safety issue: No ]The primary endpoint is the relative concentration of Mg in the core cerebral ischemic zone, compared to systemic therapeutic Mg levels, as a measure of delivery efficacy of systemic administration.
- Sampling feasibility [ Time Frame: intra-procedural (at time of first pass of retrieval device) ] [ Designated as safety issue: No ]sampling feasibility will be determined by the proportion of cases in which a cerebral circulation Mg level was successfully assayed
- Safety [ Time Frame: post-operative day 1 ] [ Designated as safety issue: Yes ]safety will be assessed by intraoperative adverse events, postoperative neurologic examination including NIH stroke scale, and postoperative brain imaging.
|Study Start Date:||March 2012|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: Endovascular Sampling
Paired sampling from the distal arterial(endovascular catheter) and peripheral venous (femoral sheath) locations in acute stroke patients undergoing endovascular recanalization who received intravenous Magnesium Sulfate as a part of the FAST-MAG study
Other: endovascular sampling
Paired sampling from the distal arterial(endovascular catheter) and peripheral venous (femoral sheath) locations: withdrawal of 3ml of blood from vasculature distal to the occlusive thrombus
|United States, California|
|University California Los Angeles: Ronald Reagan and Santa Monica Hospitals|
|Los Angeles, California, United States, 900094|
|University of Southern California University and LA County Hospitals|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||William J Mack, MD||University of Southern California|
|Principal Investigator:||Jeffrey Saver, MD||University of California, Los Angeles|