Endovascular Magnesium Sampling in Acute Stroke

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01502748

Enrollment

Registered

2012-01-02

Start date

2012-03-31

Completion date

2013-02-28

Last updated

2017-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Stroke

Keywords

stroke, Magnesium, Endovascular

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.

Interventions

OTHERendovascular 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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 95 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026