Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial
This study is currently recruiting participants.
Verified December 2011 by University of California, Los Angeles
Sponsor:
Jeffrey L. Saver
Collaborator:
Information provided by (Responsible Party):
Jeffrey L. Saver, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00059332
First received: April 23, 2003
Last updated: December 12, 2011
Last verified: December 2011
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Purpose
The goal of this study is to evaluate the effectiveness and safety of field-initiated magnesium sulfate in improving the long-term functional outcome of patients with acute stroke.
| Condition | Intervention | Phase |
|---|---|---|
|
Cerebrovascular Accident |
Drug: Magnesium Sulfate Drug: Normal Saline |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Field Administration of Stroke Therapy-Magnesium Trial: A Randomized, Double-Blind, Placebo Controlled Trial of Neuroprotective Magnesium Sulfate Therapy for Acute Stroke Initiated Within 2 Hours of Onset by Paramedics in the Field |
Resource links provided by NLM:
Further study details as provided by University of California, Los Angeles:
Primary Outcome Measures:
- The primary endpoint is the modified Rankin Scale global measure of global disability, assessed 90 days after treatment. [ Time Frame: 3 months after stroke onset ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Barthel Index measure of activities of daily living [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- NIH Stroke Scale measure of neurologic deficit [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Stroke Impact Scale measure of stroke-specific quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Symptomatic hemorrhagic transformation [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
- Recurrent ischemic stroke [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1700 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Magnesium Sulfate |
Drug: Magnesium Sulfate
Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
|
| Placebo Comparator: Normal saline |
Drug: Normal Saline
Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
|
Detailed Description:
Stroke is the third leading cause of death and the leading cause of adult disability in the United States. Each year, more than 750,000 Americans suffer a symptomatic stroke.
Currently, rt-PA is the only approved treatment for acute ischemic stroke; however, its usefulness is limited because most patients cannot reach medical attention within the necessary 3-hour time window. In addition, rt-PA cannot be given in the field because it is contraindicated for treatment of patients with brain hemorrhage.
The purpose of this multi-center, randomized, double-blind trial is to demonstrate that paramedic initiation of the neuroprotective agent magnesium sulfate in the field is an effective and safe treatment for acute stroke. This study will analyze magnesium sulfate, an experimental therapy for stroke, versus placebo among ambulance-transported patients with acute stroke. This trial will also demonstrate that paramedics can safely, effectively, and rapidly start neuroprotective therapies for stroke.
Eligibility| Ages Eligible for Study: | 40 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Suspected stroke identified by the Los Angeles Prehospital Stroke Screen
- Age 40-95, inclusive
- Last known well time within 2 hours of treatment initiation
- Deficit present for >/= 15 minutes
Exclusion Criteria:
- Coma
- Rapidly improving neurologic deficit
- Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations
- SBP < 90 or > 220
- Known severe renal dysfunction (on dialysis or known chronic creatinine > 3.0)
- Severe respiratory distress (O2 sat < 90% or respiratory rate < 12 or >/= 24)
- Known second or third degree heart block with no pacemaker in place
- Major head trauma in the last 24 hours
- Recent stroke within prior 30 days
- Patient unable to give informed consent and no available on scene consent or assent provider
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00059332
Contacts
| Contact: Jeffrey Saver, M.D. | 310-794-6379 |
Locations
| United States, California | |
| The Clinical Coordinating Center is: UCLA School of Medicine, 710 Westwood Plaza | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Jeffrey Saver, M.D. 310-794-6379 | |
| Principal Investigator: Jeffrey Saver, M.D. | |
Sponsors and Collaborators
Jeffrey L. Saver
Investigators
| Principal Investigator: | Jeffrey Saver, M.D. | UCLA School of Medicine, Study Overall Principal Investigator |
| Principal Investigator: | Sidney Starkman, M.D. | UCLA Stroke Center, Co-Principal Investigator |
| Principal Investigator: | Marc Eckstein, M.D. | Los Angeles City Emergency Medical Service, Co-Principal Investigator |
| Principal Investigator: | Samuel Stratton, MD | Los Angeles and Orange County Emergency Medical Services Agencies, Co-Principal Investigator |
| Principal Investigator: | Frank Pratt, MD | Los Angeles County Emergency Medical Service, Co-Principal Investigator |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jeffrey L. Saver, Professor of Neurology, University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00059332 History of Changes |
| Other Study ID Numbers: | U01NS44364, U01NS044364 |
| Study First Received: | April 23, 2003 |
| Last Updated: | December 12, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of California, Los Angeles:
|
stroke brain attack magnesium sulfate |
neuroprotection prehospital care emergency medical services |
Additional relevant MeSH terms:
|
Cerebral Infarction Stroke Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Magnesium Sulfate Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics Central Nervous System Depressants Anti-Arrhythmia Agents Cardiovascular Agents Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Tocolytic Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on June 13, 2013