Endovascular Magnesium Sampling in Acute Stroke

NCT ID: NCT01502748

Last Updated: 2017-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-02-28

Brief Summary

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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

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Conditions

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Acute Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

endovascular sampling

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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William Mack

Assistant Professor of Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William J Mack, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Jeffrey Saver, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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University California Los Angeles: Ronald Reagan and Santa Monica Hospitals

Los Angeles, California, United States

Site Status

University of Southern California University and LA County Hospitals

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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12BGIA8700001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HS-11-00311

Identifier Type: -

Identifier Source: org_study_id

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