Endovascular Magnesium Sampling in Acute Stroke

Acute Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01502748
• Other study ID #: HS-11-00311
• Secondary ID: 12BGIA8700001
• Status: Terminated
• Phase: N/A
• First received: December 25, 2011
• Last updated: July 27, 2017
• Start date: March 2012
• Est. completion date: February 2013

Study information

• Verified date: July 2017
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

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