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Clinical Trials/EUCTR2010-019527-58-GB
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

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.

Registry
who.int
Start Date
April 15, 2011
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
HS Lothian

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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