Intravenous MAGnesium Efficacy in Stroke

ISRCTN	ISRCTN19943732
DOI	https://doi.org/10.1186/ISRCTN19943732
Protocol serial number	G9702465
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (UK)

Submission date: 23/10/2000
Registration date: 23/10/2000
Last edited: 14/07/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof KR Lees
Scientific

The University Department of Medicine and Therapeutics
The Western Infirmary
Glasgow
G11 9NT
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	IMAGES
Study objectives	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
Ethics approval(s)	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.
Health condition(s) or problem(s) studied	Stroke
Intervention	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.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Magnesium sulphate
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	29/02/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	2700
Key inclusion criteria	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
Key exclusion criteria	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.
Date of first enrolment	01/10/1997
Date of final enrolment	29/02/2004

Locations

Countries of recruitment

United Kingdom
Scotland
Australia
Canada
China
Singapore
United States of America

Study participating centre

The University Department of Medicine and Therapeutics

Glasgow
G11 9NT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2000		Yes	No