Investigation of the effect of InterLeukin-1 receptor Antagonist on markers of inflammation in non-ST elevation acute coronary syndromes

Completed

• Conditions: on-ST elevation acute coronary syndromes; Circulatory System; Coronary syndromes

• Registration Number: ISRCTN89369318
• Lead Sponsor: niversity of Sheffield (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-03
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 186

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area under the curve of serum high sensitivity C-Reactive Protein (hsCRP) over the first seven days.

Secondary Outcome Measures

Name	Time	Method
1. Mean hsCRP at seven, 14 and 30 days<br>2. Area under the curve of Troponin-I<br>3. von Willebrand Factor (vWF) and InterLeukin-6 (IL-6)<br>4. ST segment depression on Holter monitor<br>5. Myocardial injury as determined by Gadolinium enhanced Cardiovascular Magnetic Resonance (CMR) scan<br>6. Forearm endothelial cell response<br>7. Incidence of Major Adverse Cardiovascular Events (MACE) at 30 days, three months and at one year <br>8. Flagging with Office of National Statistics (ONS) for up to five years