We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Endovascular Magnesium Sampling in Acute Stroke

This study has been terminated.
(FAST-Mag study finished)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01502748
First Posted: January 2, 2012
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
William Mack, University of Southern California
  Purpose
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.

Condition Intervention
Acute Stroke Other: endovascular sampling

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Magnesium Therapy: a Novel Platform for Neuroprotectant Sampling in Acute Stroke

Resource links provided by NLM:


Further study details as provided by William Mack, University of Southern California:

Primary Outcome Measures:
  • Magnesium concentration [ Time Frame: intra-procedure (at time of first pass of retrieval device) ]
    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.


Secondary Outcome Measures:
  • Sampling feasibility [ Time Frame: intra-procedural (at time of first pass of retrieval device) ]
    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 ]
    safety will be assessed by intraoperative adverse events, postoperative neurologic examination including NIH stroke scale, and postoperative brain imaging.


Enrollment: 2
Study Start Date: March 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01502748


Locations
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
Sponsors and Collaborators
University of Southern California
University of California, Los Angeles
Investigators
Principal Investigator: William J Mack, MD University of Southern California
Principal Investigator: Jeffrey Saver, MD University of California, Los Angeles
  More Information

Responsible Party: William Mack, Assistant Professor of Neurosurgery, University of Southern California
ClinicalTrials.gov Identifier: NCT01502748     History of Changes
Other Study ID Numbers: HS-11-00311
12BGIA8700001 ( Other Grant/Funding Number: American Heart Association )
First Submitted: December 25, 2011
First Posted: January 2, 2012
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by William Mack, University of Southern California:
stroke
Magnesium
Endovascular

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases


To Top