Condition category
Circulatory System
Date applied
10/08/2006
Date assigned
03/10/2006
Last edited
26/10/2012
Prospective/Retrospective
Prospectively 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

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 measures

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

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

http://www.shef.ac.uk/researchoffice/about

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

Results - basic reporting

Publication summary

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18298837

Publication citations

  1. 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.

Additional files

Editorial Notes