EMPIRE-Elafin Myocardial Protection from Ischaemia RepErfusion injury - Effect of elafin on myocardial injury

Phase 1

• Conditions: Myocardial ischaemia reperfusion injury Post-operative inflammation Post-ischaemic inflammatory injury

• Registration Number: EUCTR2010-019527-58-GB
• Lead Sponsor: HS Lothian

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-15
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Patients who are referred for coronary artery bypass graft surgery requiring 2 or more grafts will be approached for consent to enter the study during visits to the cardiothoracic surgery outpatient clinic.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The following exclusion criteria will apply: Contraindication to MRI scanning Emergency surgery Recent myocardial infarction (a recorded troponin elevation within 1 month of surgery) Concomitant valve or aortic surgery Re-intervention or re-do surgery Chronic renal failure (estimated glomerular filtration rate <40 ml/min) Severe respiratory disease maintenance corticosterod therapy or forced expiratory volume on one second (FEV1) < 50% predicted Congestive cardiac failure A history of chronic inflammatory illness Patients unable to give informed consent will not be approached.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main question is whether delivering the anti-elastase elafin by infusion during cardiac bypass surgery can reduce the myocardial injury that results from a period of reduced blood flow (ischaemia) and subsequent inflammation.;Primary end point(s): The primary endpoint will be area under the curve for plasma troponin T release from timepoint 0 to 48 h following coronary artery bypass surgery.;Secondary Objective: The secondary questions are whether in addition to reducing myocardial injury elafin can reduce systemic markers of inflammatory activity and neutrophil activation, macrophage infiltration into the myocardium and length of post-operative stay in ITU.