Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

December 25, 2011
February 16, 2013
March 2012
February 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01502748 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Acute Stroke
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
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
Intervention: Other: endovascular sampling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
40 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01502748
HS-11-00311, 12BGIA8700001
Yes
William Mack, University of Southern California
University of Southern California
University of California, Los Angeles
Principal Investigator: William J Mack, MD University of Southern California
Principal Investigator: Jeffrey Saver, MD University of California, Los Angeles
University of Southern California
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP