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Endovascular Magnesium Sampling in Acute Stroke

Primary Purpose

Acute Stroke

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
endovascular sampling
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Stroke focused on measuring stroke, Magnesium, Endovascular

Eligibility Criteria

40 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University California Los Angeles: Ronald Reagan and Santa Monica Hospitals
  • University of Southern California University and LA County Hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endovascular Sampling

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Sampling feasibility
sampling feasibility will be determined by the proportion of cases in which a cerebral circulation Mg level was successfully assayed
Safety
safety will be assessed by intraoperative adverse events, postoperative neurologic examination including NIH stroke scale, and postoperative brain imaging.

Full Information

First Posted
December 25, 2011
Last Updated
July 27, 2017
Sponsor
University of Southern California
Collaborators
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT01502748
Brief Title
Endovascular Magnesium Sampling in Acute Stroke
Official Title
Magnesium Therapy: a Novel Platform for Neuroprotectant Sampling in Acute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
FAST-Mag study finished
Study Start Date
March 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
stroke, Magnesium, Endovascular

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endovascular Sampling
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
endovascular sampling
Intervention Description
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
Primary Outcome Measure Information:
Title
Magnesium concentration
Description
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.
Time Frame
intra-procedure (at time of first pass of retrieval device)
Secondary Outcome Measure Information:
Title
Sampling feasibility
Description
sampling feasibility will be determined by the proportion of cases in which a cerebral circulation Mg level was successfully assayed
Time Frame
intra-procedural (at time of first pass of retrieval device)
Title
Safety
Description
safety will be assessed by intraoperative adverse events, postoperative neurologic examination including NIH stroke scale, and postoperative brain imaging.
Time Frame
post-operative day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with acute cerebral ischemia due to ICA or MCA occlusion, Patient already enrolled in the NIH FAST-MAG clinical trial, Patient's clinical attending physician plans mechanical embolectomy procedure as part of routine clinical care. Age 40-95 inclusive (age criteria for FAST-MAG Trial). Exclusion Criteria: Technical inability to navigate microcatheter to target clot. Patient or surrogate unavailable for consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William J Mack, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey Saver, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University California Los Angeles: Ronald Reagan and Santa Monica Hospitals
City
Los Angeles
State/Province
California
ZIP/Postal Code
900094
Country
United States
Facility Name
University of Southern California University and LA County Hospitals
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Endovascular Magnesium Sampling in Acute Stroke

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