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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 25, 2011

Last Updated Date

February 16, 2013

Start Date ^ICMJE

March 2012

Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01502748 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Endovascular Magnesium Sampling in Acute Stroke

Official Title ^ICMJE

Magnesium Therapy: a Novel Platform for Neuroprotectant Sampling in Acute Stroke

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Acute Stroke

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2013

Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 95 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01502748

Other Study ID Numbers ^ICMJE

HS-11-00311, 12BGIA8700001

Has Data Monitoring Committee

Yes

Responsible Party

William Mack, University of Southern California

Study Sponsor ^ICMJE

University of Southern California

Collaborators ^ICMJE

University of California, Los Angeles

Investigators ^ICMJE

Principal Investigator:	William J Mack, MD	University of Southern California
Principal Investigator:	Jeffrey Saver, MD	University of California, Los Angeles

Information Provided By

University of Southern California

Verification Date

February 2013

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

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