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Completed

NCT Number: NCT00059332

Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial

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.

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Key information

Conditions

Cerebrovascular Accident Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

40 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Clinical Coordinating Center is: UCLA School of Medicine, 710 Westwood Plaza

Los Angeles, California, 90095, United States

About this study

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, tissue plasminogen activator (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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Systolic Blood Pressure (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

Treatment and study plan

Magnesium sulfate

Drug

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.

Other names: MA 135 magnesium sulfate heptahydrate

normal saline

Drug

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.

Other names: SO155 sodium chloride

Primary outcomes

  1. Modified Rankin Scale

    Time frame: 3 months after stroke onset

    Modified Rankin Scales (mRS) is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes.

    0 No symptoms at all

    • No significant disability despite symptoms; able to carry out all usual duties and activities
    • Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
    • Moderate disability; requiring some help, but able to walk without assistance
    • Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    • Severe disability; bedridden, incontinent and requiring constant nursing care and attention
    • Dead

Secondary outcomes

  1. Modified Rankin Score of 0 or 1

    Time frame: 3 months

    Minimal or no disability based on the modified Rankin score

  2. Modified Rankin Score ≤2

    Time frame: 3 months

    Functional independence based on modified Rankin score

  3. NIH Stroke Scale

    Time frame: 3 months

    The National Institute of Health Stroke Scale (NIHSS) is a measure of neurologic deficit. Total Score range 0-42, with higher scores indicating greater severity. The 11 domains assessed are:

    1a-c Level of consciousness 2. Best Gaze 3. Visual 4. Facial Palsy 5a. Motor left arm 5b. Motor right arm 6a. Motor left leg 6b. Motor right leg 7. Limb Ataxia 8. Sensory 9. Best Language 10. Dysarthria 11. Extinction and Inattention

  4. Barthel Index

    Time frame: 3 months

    The Barthel Index is a measure of activities of daily living. Total score is calculated by addition of subscale scores. Total score range is 0-100, with higher scores indicating better outcomes. The ten subitems are:

    FEEDING (Subscale range is 0-10) BATHING (Subscale range is 0-5) GROOMING (Subscale range is 0-5) DRESSING (Subscale range is 0-10) BOWELS (Subscale range is 0-10) BLADDER (Subscale range is 0-10) TOILET USE (Subscale range is 0-10) TRANSFERS (Subscale range is 0-15) MOBILITY (Subscale range is 0-15) STAIRS (Subscale range is 0-10)

  5. Stroke Impact Scale

    Time frame: 3 months

    The Stroke Impact Scale (SIS) is a measure of stroke-specific quality of life. The scale assesses 8 domains. Scores for each domain range from 0-100, with higher scores indicating better outcomes.

    • Physical problems
    • Memory and thinking
    • Mood and emotions
    • Communication, reading and understanding
    • Daily activities
    • Mobility at home and in the community
    • Affected hand use
    • Hobbies and activities participation

  6. Serious Adverse Events

    Time frame: 3 months

  7. Symptomatic Intracranial Hemorrhage

    Time frame: 3 month

  8. Mortality

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Jeffrey L. Saver

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study 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

Acronym: FAST-MAG

Important dates

Study start
2005
Primary completion
2013
Study completion
2013
First posted
Apr 24, 2003
Registry last updated
Aug 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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