FAST-MAG
Field Administration of Stroke Therapy - Magnesium Phase III Trial
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Status:
Ongoing. Through 9/1/09, 821 patients had been enrolled. Median interval from last known well to start of study agent is 48 minutes. Treatment was initiated within 1 hour of onset in 73% and between 1-2 hours in 25%. Median pretreatment stroke severity on the Los Angeles Motor Scale (LAMS) is 4. Adjudicated final diagnoses are acute cerebral ischemia in 73%, intracerebral hemorrhage in 24%, and stroke mimic in 3%.
Purpose:
To evaluate the efficacy of hyperacute, paramedic-initiated magnesium sulfate administration in improving the long-term functional outcome of patients with acute stroke.
Interventions:
Magnesium
Ion channel blocker (blocks voltage gated calcium channels and NMDA receptors)
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Location(s):
31 EMS Provider Agencies and 55 emergency receiving hospitals in Los Angeles County
Year Started:
2005
Design:
Multicenter, randomized, double-blind, placebo-controlled trial.
Inclusion Criteria
Probable stroke patients (both cerebral infarction and intracerebral hemorrhage patients), as identified by the Los Angeles Prehospital Stroke Screen (LAPSS) whose neurological deficits have been present for at least 15 minutes, and who can be treated within 2 hours of symptom onset, will be eligible for this study.
Exclusion Criteria
Coma, rapidly improving neurologic deficit, 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 > 20), 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 Involvement:
After being assessed for possible stroke, eligible patients will be randomized to receive either intravenous magnesium sulfate or a matched placebo. Half of the participants will be treated within one hour of stroke, and half will be treated within 1 - 2 hours. Patients in the treatment group will receive a 4-gram bolus dose of magnesium (Mg) delivered over 15 minutes by paramedics in the field, followed by an in-hospital infusion of 16 grams Mg delivered over 24 hours. Patients in the control group will receive placebo on an identical time schedule. Patients will be followed for 90 days.
Primary Outcome:
Functional outcome at 90 days, as measured by the modified Rankin scale (MRS).
Secondary Outcome:
Neurological deficit, as measured by the National Institutes of Health Stroke Scale (NIHSS), disability, as defined by the Barthel Index (BI), and quality of life, as assessed by the Stroke Impact Scale (SIS).
Results:
Through 9/1/09, 821 patients had been enrolled. Median interval from last known well to start of study agent is 48 minutes. Treatment was initiated within 1 hour of onset in 73% and between 1-2 hours in 25%. Median pretreatment stroke severity on the Los Angeles Motor Scale (LAMS) is 4. Adjudicated final diagnoses are acute cerebral ischemia in 73%, intracerebral hemorrhage in 24%, and stroke mimic in 3%.
Source of Information:
Presented at 30th International Stroke Conference [February 2005].
ClinicalTrials.gov. Press release 9/26/03.
Presented at the 2006 International Stroke Conference [February 2006].
Presented at the 2008 International Stroke Conference (February 2008).
Presented at the 2009 International Stroke Conference (February 2009).
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Web Links and Publications:
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This information last updated on: 9/23/2009
Reviewed on: 09/16/2009.
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