Post-ischaemic inflammatory myocardial injury Circulatory System Myocardial injury
Conditions
Interventions
Current interventions as of 23/07/2013:
80 patients will receive an initial magnetic resonance imaging (MRI) scan. They will be randomised to either placebo or Elafin (200 mg) and patients will receiv
Sponsors
NHS Lothian and the University of Edinburgh (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients (males and females, 18 years or older; no upper age limit) who are referred for coronary artery bypass graft surgery requiring two or more grafts will be approached for consent to enter the study during visits to the cardiothoracic surgery outpatient clinic.
Exclusion criteria
Exclusion criteria: 1. Recent myocardial infarction (a recorded troponin elevation within 1 month of surgery) 2. Emergency surgery 3. Concomitant valve or aortic surgery 4. Re-intervention or re-do surgery 5. Chronic renal failure (estimated glomerular filtration rate less than 40 ml/min) 6. Severe respiratory disease (maintenance corticosteroid therapy or forced expiratory volume in one second [FEV1] less than 50% predicted) 7. Severe left ventricular dysfunction (ejection fraction less than 30%) 8. Contraindication to magnetic resonance imaging (MRI) scanning or a history of chronic inflammatory illness, such as inflammatory joint disease, connective tissue disorder (added 23/07/2013: not applicable to extension participants) 9. Patients unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve for plasma troponin I concentration profile over the first 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The effect of Elafin on myocardial injury and inflammation will be further quantified by comparing infarct volume and macrophage infiltration before and after surgery 2. Infarct volume and macrophage infiltration will be quantified using MRI together with late gadolinium enhancement and accumulation of ultra-small superparamagnetic particles of iron oxide (USPIO) respectively. USPIO contrast acts as a cellular marker through the detection of macrophage-mediated inflammation within tissues (added 23/07/2013: not applicable to extension participants) 3. Elafin's effect on inflammatory activation will be assessed by comparing peak and area under the curve of plasma CRP and cytokine (IL-6, TNF-a and IL-8) concentrations 4. Neutrophil activation will be assessed by measuring the white cell and neutrophil differential counts and measuring peak and area under the curve of plasma myeloperoxidase and elastase concentrations 5. Post-operative intensive therapy unit (ITU) stay will be recorded from the end of the operation (as documented on the anaesthetic chart) until the ITU team consider the patient fit for 'step down' either to cardiothoracic high dependency unit (HDU) or general surgical ward. It will be measured in hours. | — |
Countries
United Kingdom
Outcome results
None listed