Endovascular Magnesium Sampling in Acute Stroke

Not Applicable

Terminated

• Conditions: Acute Stroke
• Interventions: Other: endovascular sampling

• Registration Number: NCT01502748
• Lead Sponsor: University of Southern California

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 available

Study Timeline

• Study First Submitted: 2011-12-25
• Study First Submitted QC: 2011-12-30
• Study First Posted: 2012-01-02
• Study Start: 2012-03
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endovascular Sampling	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

Primary Outcome Measures

Name	Time	Method
Magnesium concentration	intra-procedure (at time of first pass of retrieval device)	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

Name	Time	Method
Sampling feasibility	intra-procedural (at time of first pass of retrieval device)	sampling feasibility will be determined by the proportion of cases in which a cerebral circulation Mg level was successfully assayed
Safety	post-operative day 1	safety will be assessed by intraoperative adverse events, postoperative neurologic examination including NIH stroke scale, and postoperative brain imaging.

Trial Locations

Locations (2)

University California Los Angeles: Ronald Reagan and Santa Monica Hospitals; 🇺🇸 Los Angeles, California, United States

University of Southern California University and LA County Hospitals; 🇺🇸 Los Angeles, California, United States