Endovascular Magnesium Sampling in Acute Stroke

This study has been completed.
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
William Mack, University of Southern California
ClinicalTrials.gov Identifier:
NCT01502748
First received: December 25, 2011
Last updated: February 16, 2013
Last verified: February 2013
  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 Phase
Acute Stroke
Other: endovascular sampling
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   40 Years to 95 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 25, 2011
Last Updated: February 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Southern California:
stroke
Magnesium
Endovascular

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014