Intravenous MAGnesium Efficacy in Stroke
| ISRCTN | ISRCTN19943732 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19943732 |
| Secondary identifying numbers | G9702465 |
- 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
Professor KR Lees
Scientific
Scientific
The University Department of Medicine and Therapeutics
The Western Infirmary
Glasgow
G11 9NT
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Magnesium sulphate |
| Primary outcome measure | 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 study start date | 01/10/1997 |
| Completion date | 29/02/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- Australia
- Canada
- China
- Scotland
- Singapore
- United Kingdom
- United States of America
Study participating centre
The University Department of Medicine and Therapeutics
Glasgow
G11 9NT
United Kingdom
G11 9NT
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
