EUCTR2013-001922-24-GB
Active, not recruiting
Phase 1
The effect of remote ischaemic preconditioning and glyceryl trinitrate on peri-operative myocardial injury in cardiac bypass surgery patients (ERIC-GTN study)- a four arm randomised controlled trial - Investigation into the role of GTN & RIPC in cardiac surgery
niversity College London (UCL)0 sites260 target enrollmentSeptember 19, 2013
ConditionsWe are investigating the phenomenon of ischaemic-reperfusion injury. Reperfusion of the ischaemic myocardium is known to cause further myocardial damage. We wish to investigate the phenomenon of Remote Ischaemic Preconditionoing along with Glyceryl Trinitrate to reduce reperfusion injury.MedDRA version: 16.0Level: PTClassification code 10051624Term: Myocardial reperfusion injurySystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- We are investigating the phenomenon of ischaemic-reperfusion injury. Reperfusion of the ischaemic myocardium is known to cause further myocardial damage. We wish to investigate the phenomenon of Remote Ischaemic Preconditionoing along with Glyceryl Trinitrate to reduce reperfusion injury.
- Sponsor
- niversity College London (UCL)
- Enrollment
- 260
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Adult patients (\>18 years old) undergoing CABG and/or valve surgery involving cardiopulmonary bypass capable of consenting themselves.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 36
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 200
Exclusion Criteria
- •1\.Allergies to excipients of IMP and placebo
- •2\.Chronic Renal failure (eGFR\<30 ml/min/kg)
- •3\.Severe liver disease
- •4\.Peripheral arterial disease
- •5\.Pregnant or lactating women
- •6\.Any other contraindications to glyceryl trinitrate as per the summary of product characteristics.
Outcomes
Primary Outcomes
Not specified
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