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ISRCTN
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ISRCTN19943732
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DOI
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10.1186/ISRCTN19943732
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Intravenous MAGnesium Efficacy in Stroke
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Scientific title
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Acronym
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IMAGES
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Serial number at source
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G9702465
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Study hypothesis
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To determine if magnesium sulphate therapy is an effective and safe treatment for acute stroke. Magnesium does not cause the same troublesome side-effects affecting many other neuroprotective compounds
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Lay summary
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Not provided at time of registration
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Ethics approval
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Ethics approval information added as of 19/07/2007: In the UK the study has Multicentre Research Ethics Committee approval. Local institutional review boards have approved it in centres across five continents.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Australia, Canada, China, Singapore, United Kingdom, United States of America, Europe, International
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Disease/condition/study domain
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Stroke
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Participants - inclusion criteria
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1. Clinically diagnosed acute stroke with limb weakness
2. Symptoms present for at least 1 h and treatment initiation possible within 12 h of onset
3. Aged 18 or older
4. Previously independent in activities of daily living
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Participants - exclusion criteria
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1. Co-existing disease likely to prevent outcome assessment.
2. Known chronic renal impairment.
3. Known intracerebral pathology other than stroke e.g. intracranial abscess, subarachnoid haemorrhage, brain tumour.
4. Known indication or contraindication for magnesium therapy.
5. Coma.
6. Concomitant experimental therapy.
7. Pregnancy.
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Anticipated start date
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01/10/1997
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Anticipated end date
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29/02/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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2700
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Interventions
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The study aims to review the efficacy of intravenous magnesium as a treatment for acute stroke when compared to placebo. Pre-clinical animal models of acute stroke show that magnesium has similar efficacy to other neuroprotective compounds. Clinical trials of magnesium show that it is safe and well tolerated.
A subgroup analysis of patients recruited within the 1-6 h, patients with haemorrhagic stroke and those with lacunar cortical events will be undertaken.
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Primary outcome measure(s)
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The primary endpoint of the study is the proportion of patients dead or disabled at 90 days. Comparison between groups will be by intention to treat analysis. Disability will be measured by the Barthel Index. Patients scoring greater than or equal to 60 will be considered independent and those scoring less than 60 will be considered disabled. Patients who die will be allocated a Barthel score of 0. Overall mortality and disability by Rankin Score will also be carried out.
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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2000 initial results on http://www.ncbi.nlm.nih.gov/pubmed/11714436
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Contact name
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Professor
KR
Lees
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Address
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The University Department of Medicine and Therapeutics
The Western Infirmary
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City/town
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Glasgow
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Zip/Postcode
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G11 9NT
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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23/10/2000
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Last edited
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28/09/2012
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Date ISRCTN assigned
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23/10/2000
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