Endovascular Magnesium Sampling in Acute Stroke

Magnesium Therapy: a Novel Platform for Neuroprotectant 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 Overview

• Status: Terminated
• Conditions: Acute Stroke
• Intervention / Treatment: Other: endovascular sampling

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 900094
      • University California Los Angeles: Ronald Reagan and Santa Monica Hospitals
    • Los Angeles, California, United States, 90033
      • University of Southern California University and LA County Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient with acute cerebral ischemia due to ICA or MCA occlusion,
2. Patient already enrolled in the NIH FAST-MAG clinical trial,
3. Patient's clinical attending physician plans mechanical embolectomy procedure as part of routine clinical care.
4. Age 40-95 inclusive (age criteria for FAST-MAG Trial).

Exclusion Criteria:

1. Technical inability to navigate microcatheter to target clot.
2. Patient or surrogate unavailable for consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnesium concentration	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.	intra-procedure (at time of first pass of retrieval device)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sampling feasibility	sampling feasibility will be determined by the proportion of cases in which a cerebral circulation Mg level was successfully assayed	intra-procedural (at time of first pass of retrieval device)
Safety	safety will be assessed by intraoperative adverse events, postoperative neurologic examination including NIH stroke scale, and postoperative brain imaging.	post-operative day 1

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: December 25, 2011
• First Submitted That Met QC Criteria: December 30, 2011
• First Posted (Estimate): January 2, 2012

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 27, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: stroke; Magnesium; Endovascular
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: HS-11-00311; 12BGIA8700001 (Other Grant/Funding Number: American Heart Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No