Contact information
Type
Scientific
Primary contact
Prof David Crossman
ORCID ID
Contact details
Cardiovascular Research Unit
School of Medicine & Biomedical Sciences
University of Sheffield
Beech Hill Road
Sheffield
S10 2RX
United Kingdom
+44 (0) 114 2261432
d.c.crossman@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
101105
Study information
Scientific title
Acronym
MRC-ILA-HEART study
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?
Ethics approval
Leeds (West) Research Ethics Committee, 18th December 2006, ref: 06/Q1205/234.
Study design
Randomised double blind placebo controlled multi-centre phase II clinical trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Phase II
Drug names
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 trial start date
01/01/2007
Overall trial end date
01/01/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
186
Participant 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
Recruitment start date
01/01/2007
Recruitment end date
01/01/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cardiovascular Research Unit
Sheffield
S10 2RX
United Kingdom
Sponsor information
Organisation
University of Sheffield (UK)
Sponsor details
Research Office
Research Services
231 Glossop Road
Sheffield
S10 2GW
United Kingdom
+44 (0) 114 2221442
m.e.eastcott@sheffield.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council grant award (ref no: G0502131)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18298837
Publication citations
-
Results
Crossman DC, Morton AC, Gunn JP, Greenwood JP, Hall AS, Fox KA, Lucking AJ, Flather MD, Lees B, Foley CE, Investigation of the effect of Interleukin-1 receptor antagonist (IL-1ra) on markers of inflammation in non-ST elevation acute coronary syndromes (The MRC-ILA-HEART Study)., Trials, 2008, 9, 8, doi: 10.1186/1745-6215-9-8.