Endovascular Magnesium Sampling in Acute Stroke

NCT01502748 | Terminated

• 2 other identifiers: HS-11-0031112BGIA8700001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Stroke

Keywords

stroke; Magnesium; Endovascular

Outcome Measures

Primary Outcomes (1)

• 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.

  intra-procedure (at time of first pass of retrieval device)

Secondary Outcomes (2)

• Sampling feasibility

  intra-procedural (at time of first pass of retrieval device)

• Safety

  post-operative day 1

Study Arms (1)

Endovascular Sampling

EXPERIMENTAL

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

Interventions

endovascular sampling OTHER

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

Endovascular Sampling

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Technical inability to navigate microcatheter to target clot.
• Patient or surrogate unavailable for consent

Sponsors & Collaborators

• University of Southern California: lead
• University of California, Los Angeles: collaborator

Study Sites (2)

University California Los Angeles: Ronald Reagan and Santa Monica Hospitals

Los Angeles, California, 900094, United States

Location

University of Southern California University and LA County Hospitals

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• William J Mack, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Jeffrey Saver, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurosurgery

Study Record Dates

• First Submitted: December 25, 2011
• First Posted: January 2, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: August 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)