Condition category
Circulatory System
Date applied
23/10/2000
Date assigned
23/10/2000
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Professor KR Lees

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9702465

Study information

Scientific title

Acronym

IMAGES

Study hypothesis

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

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.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Magnesium sulphate

Primary outcome measures

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.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/1997

Overall trial end date

29/02/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2700

Participant 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.

Recruitment start date

01/10/1997

Recruitment end date

29/02/2004

Locations

Countries of recruitment

Australia, Canada, China, Singapore, United Kingdom, United States of America

Trial participating centre

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

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2000 results in: http://www.ncbi.nlm.nih.gov/pubmed/11714436

Publication citations

  1. Results

    Bradford A, Lees K, Design of the Intravenous Magnesium Efficacy in Acute Stroke (IMAGES) trial., Curr Control Trials Cardiovasc Med, 2000, 1, 3, 184-190, doi: 10.1186/cvm-1-3-184.

Additional files

Editorial Notes