EUCTR2010-019527-58-GB
Active, not recruiting
Phase 1
EMPIRE-Elafin Myocardial Protection from Ischaemia RepErfusion injury - Effect of elafin on myocardial injury
HS Lothian0 sites80 target enrollmentApril 15, 2011
DrugsELAFIN
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Myocardial ischaemia reperfusion injury Post-operative inflammation Post-ischaemic inflammatory injury
- Sponsor
- HS Lothian
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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