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| [ Print-friendly version ] |
| Investigation of the effect of InterLeukin-1 receptor Antagonist on markers of inflammation in non-ST elevation acute coronary syndromes |
| ISRCTN | ISRCTN89369318 |
| ClinicalTrials.gov identifier | |
| Public title | Investigation of the effect of InterLeukin-1 receptor Antagonist on markers of inflammation in non-ST elevation acute coronary syndromes |
| Scientific title | |
| Acronym | MRC-ILA-HEART study |
| Serial number at source | 101105 |
| Study hypothesis | Does treatment of Non-ST Elevation Myocardial Infarction (NSTEMI)/Acute Coronary Syndrome (ACS) with InterLeukin-1 receptor antagonist (IL-1ra) alter the inflammatory process involved in this condition? |
| Lay summary | |
| Ethics approval | Approval received from the Leeds (West) Research Ethics Committee on the 18th December 2006 (REC reference no.: 06/Q1205/234). |
| Study design | This is a randomised, double blind, placebo controlled multi-centre phase II clinical trial. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Non-ST elevation acute coronary syndromes |
| Participants - inclusion criteria |
1. Aged over 18 years of age
2. Acute severe cardiac chest pain consistent with an acute coronary syndrome 3. Less than 48 hours from onset of symptoms that led to hospital admissions 4. And at least one of the following: a. Horizontal or down-sloping ST depression of at least 0.5mm in at least two Electrocardiogram (ECG) leads b. a raised troponin as defined by local parameters specified at each centre c. Other ECG changes consistent with acute myocardial ischaemia (e.g. T-wave inversion of at least 3 mm, in at least two leads of the ECG, or new onset bundle branch block) and an elevated level of Troponin above local laboratory values indicating myocardial damage |
| Participants - exclusion criteria |
1. Less than 18 years of age
2. Persistent ST elevation on the presenting ECG 3. Intention to treat with an urgent reperfusion strategy (thrombolysis or primary percutaneous coronary intervention) 4. Percutaneous coronary intervention within previous three months 5. Previous coronary artery bypass grafting 6. ECG showing paced rhythm 7. Cardiogenic shock (as defined in the Trial Manual) 8. Any serious co-morbidity which makes it unlikely that the patient will complete trial procedures and follow-up 9. Treatment or under active follow-up for rheumatoid arthritis, other connective tissue diseases or inflammatory bowel disease 10. End stage renal disease or a Creatinine more than 220 µmol/L 11. Pregnancy or suspected pregnancy (any potential female participant of child bearing age will need a negative pregnancy test prior to study entry) 12. Eosinophilia 13. Anti-Tumour Necrotising Factor (TNF) biologies 14. Active infection 15. Malignancy |
| Anticipated start date | 01/01/2007 |
| Anticipated end date | 01/01/2009 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 186 |
| Interventions | Eligible patients will be randomised in equal proportions between IL-1ra and placebo, receiving either a once daily, subcutaneous (s.c.) injection of IL-1ra (dose 100 mg per 24 hours) for 14 days, or a daily s.c. injection of placebo for 14 days. |
| Primary outcome measure(s) | Area under the curve of serum high sensitivity C-Reactive Protein (hsCRP) over the first seven days. |
| Secondary outcome measure(s) |
1. Mean hsCRP at seven, 14 and 30 days
2. Area under the curve of Troponin-I 3. von Willebrand Factor (vWF) and InterLeukin-6 (IL-6) 4. ST segment depression on Holter monitor 5. Myocardial injury as determined by Gadolinium enhanced Cardiovascular Magnetic Resonance (CMR) scan 6. Forearm endothelial cell response 7. Incidence of Major Adverse Cardiovascular Events (MACE) at 30 days, three months and at one year 8. Flagging with Office of National Statistics (ONS) for up to five years |
| Sources of funding | Medical Research Council grant award (ref no: G0502131) |
| Trial website | |
| Publications | |
| Contact name | Prof David Crossman |
| Address |
Cardiovascular Research Unit
School of Medicine & Biomedical Sciences University of Sheffield Beech Hill Road |
| City/town | Sheffield |
| Zip/Postcode | S10 2RX |
| Country | United Kingdom |
| Tel | +44 (0) 114 2261432 |
| Fax | +44 (0) 114 2711863 |
| d.c.crossman@sheffield.ac.uk | |
| Sponsor | University of Sheffield (UK) |
| Address |
Research Office
Research Services 231 Glossop Road |
| City/town | Sheffield |
| Zip/Postcode | S10 2GW |
| Country | United Kingdom |
| Tel | +44 (0) 114 2221442 |
| Fax | +44 (0) 114 2221452 |
| m.e.eastcott@sheffield.ac.uk | |
| Sponsor website: | http://www.shef.ac.uk/researchoffice/about |
| Date applied | 10/08/2006 |
| Last edited | 25/04/2008 |
| Date ISRCTN assigned | 03/10/2006 |
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