Investigation of the effect of InterLeukin-1 receptor Antagonist on markers of inflammation in non-ST elevation acute coronary syndromes
| ISRCTN | ISRCTN89369318 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89369318 |
| Secondary identifying numbers | 101105 |
- Submission date
- 10/08/2006
- Registration date
- 03/10/2006
- Last edited
- 26/10/2012
- 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 David Crossman
Scientific
Scientific
Cardiovascular Research Unit
School of Medicine & Biomedical Sciences
University of Sheffield
Beech Hill Road
Sheffield
S10 2RX
United Kingdom
| Phone | +44 (0) 114 2261432 |
|---|---|
| d.c.crossman@sheffield.ac.uk |
Study information
| Study design | Randomised double blind placebo controlled multi-centre phase II clinical trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | MRC-ILA-HEART study |
| Study objectives | 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? |
| Ethics approval(s) | Leeds (West) Research Ethics Committee, 18th December 2006, ref: 06/Q1205/234. |
| Health condition(s) or problem(s) studied | Non-ST elevation acute coronary syndromes |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | InterLeukin-1 receptor antagonist |
| Primary outcome measure | Area under the curve of serum high sensitivity C-Reactive Protein (hsCRP) over the first seven days. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/01/2007 |
| Completion date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 186 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 01/01/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cardiovascular Research Unit
Sheffield
S10 2RX
United Kingdom
S10 2RX
United Kingdom
Sponsor information
University of Sheffield (UK)
University/education
University/education
Research Office
Research Services
231 Glossop Road
Sheffield
S10 2GW
England
United Kingdom
| Phone | +44 (0) 114 2221442 |
|---|---|
| m.e.eastcott@sheffield.ac.uk | |
| Website | http://www.shef.ac.uk/researchoffice/about |
"ROR" |
https://ror.org/05krs5044 |
Funders
Funder type
Research council
Medical Research Council grant award (ref no: G0502131)
No information available
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 | 25/02/2008 | Yes | No |
