A randomised control trial investigating the effect of remote ischaemic preconditioning and glyceryl trinitrate on peri-operative myocardial injury in cardiac bypass surgery patients (ERIC-GTN study)
Phase 1
- 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.MedDRA version: 16.0Level: PTClassification code 10051624Term: Myocardial reperfusion injurySystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2013-001922-24-GB
- Lead Sponsor
- niversity College London (UCL)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 260
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method