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Home > "F" Clinical Trials Conditions > Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial  Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial
Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial
For Condition: Cerebrovascular Accident
Status: Not yet recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 40 Years/95 Years
Genders: Both
Protocol Entry 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 legally authorized representative to provide informed consent
Total Enrollment: 1298
Location and Contact Information:
Overall Study Official:
SidneyStarkman, , UCLA Stroke Center, co-Principal Investigator
The Clinical Coordinating Center is: UCLA School of Medicine, 710 Westwood Plaza
Los Angeles, California, 90095
United States
Jeffrey Saver 310-794-6379
Additional Information:
Study ID Numbers: R01NS44364;
Study Start Date: July 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059332
Other Cerebrovascular Accident Studies:
1. Honolulu Heart Program-Study of Stroke and Dementia
2. A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients with Acute Ischemic Stroke
3. Periodontitis and Cardiovascular Events or "PAVE"
4. Flavonoids and Cardiovascular Disease
5. The ARIC and Neurocognitive Longitudinal Study
Related Studies:
Other Cerebrovascular Accident Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial
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