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ISRCTN
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ISRCTN82061264
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ClinicalTrials.gov identifier
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Public title
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Elafin Myocardial Protection from Ischaemia RepErfusion injury
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Scientific title
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A randomised trial to investigate the effect of Elafin on myocardial injury and inflammation in coronary artery bypass surgery
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Acronym
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The EMPIRE study
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Serial number at source
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010506
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Study hypothesis
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Elafin has cardioprotective effects in myocardial injury.
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Lay summary
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Ethics approval
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Scotland A Research Ethics Committee, approved on 18/02/2011, ref:11/MRE00/5
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Study design
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Single centre randomised double blinded placebo controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Post-ischaemic inflammatory myocardial injury
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
9. Patients unable to give informed consent
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Anticipated start date
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01/03/2011
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Anticipated end date
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01/03/2014
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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80
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Interventions
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Patients will receive an initial magnetic resonance imaging (MRI) scan. They will be randomised to either placebo or Elafin (200 mg) and patients will receive an infusion of this during cardiac bypass surgery. During and after surgery blood samples will be taken up to 48 hours post-surgery. A second MRI scan will be performed after 7 ± 2 days. After this scan patients will receive an infusion of Feraheme®. A 3rd MRI scan will be performed 24 hours after the 2nd scan which will be the end of the trial for patients.
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Primary outcome measure(s)
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Area under the curve for plasma troponin I concentration profile over the first 48 hours
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Secondary outcome measure(s)
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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.
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 hours.
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Sources of funding
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1. Medical Research Council (MRC) (UK) (ref: 96182)
2. Chest Heart Stroke Scotland (UK) (ref: r11/A135)
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Trial website
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Publications
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Contact name
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Dr
Peter
Henriksen
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Address
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Department of Cardiology
Western General Hospital
Crewe Road
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City/town
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Edinburgh
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Zip/Postcode
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EH$ 2XU
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Country
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United Kingdom
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Tel
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+44 (0)131 5373834
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Fax
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+44 (0)8701 231653
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Email
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phenrik1@staffmail.ed.ac.uk
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Sponsor
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NHS Lothian and the University of Edinburgh (UK)
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Address
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The Queen's Medical Research Institute
47 Little France Crescent
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City/town
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Edinburgh
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Zip/Postcode
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EH16 4TJ
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Country
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United Kingdom
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Tel
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+44 (0)13 1242 3330
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Fax
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+44 (0)13 1242 3343
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Email
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Karen.maitland@luht.scot.nhs.uk
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Sponsor website:
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http://www.nhslothian.scot.nhs.uk/
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Date applied
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26/01/2011
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Last edited
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19/05/2011
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Date ISRCTN assigned
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14/03/2011
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