Endovascular Magnesium Sampling in Acute Stroke
This study has been completed.
Sponsor:
University of Southern California
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
William Mack, University of Southern California
ClinicalTrials.gov Identifier:
NCT01502748
First received: December 25, 2011
Last updated: February 16, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Stroke |
Other: endovascular sampling |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Magnesium Therapy: a Novel Platform for Neuroprotectant Sampling in Acute Stroke |
Resource links provided by NLM:
Further study details as provided by University of Southern California:
Primary Outcome Measures:
- Magnesium concentration [ Time Frame: intra-procedure (at time of first pass of retrieval device) ] [ Designated as safety issue: No ]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:
- Sampling feasibility [ Time Frame: intra-procedural (at time of first pass of retrieval device) ] [ Designated as safety issue: No ]sampling feasibility will be determined by the proportion of cases in which a cerebral circulation Mg level was successfully assayed
- Safety [ Time Frame: post-operative day 1 ] [ Designated as safety issue: Yes ]safety will be assessed by intraoperative adverse events, postoperative neurologic examination including NIH stroke scale, and postoperative brain imaging.
| Enrollment: | 2 |
| Study Start Date: | March 2012 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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
|
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
|
Eligibility| Ages Eligible for Study: | 40 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Technical inability to navigate microcatheter to target clot.
- Patient or surrogate unavailable for consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01502748
Locations
| United States, California | |
| University California Los Angeles: Ronald Reagan and Santa Monica Hospitals | |
| Los Angeles, California, United States, 900094 | |
| University of Southern California University and LA County Hospitals | |
| Los Angeles, California, United States, 90033 | |
Sponsors and Collaborators
University of Southern California
University of California, Los Angeles
Investigators
| Principal Investigator: | William J Mack, MD | University of Southern California |
| Principal Investigator: | Jeffrey Saver, MD | University of California, Los Angeles |
More Information
No publications provided
| Responsible Party: | William Mack, Assistant Professor of Neurosurgery, University of Southern California |
| ClinicalTrials.gov Identifier: | NCT01502748 History of Changes |
| Other Study ID Numbers: | HS-11-00311, 12BGIA8700001 |
| Study First Received: | December 25, 2011 |
| Last Updated: | February 16, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Southern California:
|
stroke Magnesium Endovascular |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Brain Infarction Brain Ischemia Neuroprotective Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013