Recruitment

Recruitment Status
Completed
Estimated Enrollment
236

Inclusion Criterias

Able to give consent
Age > 18 years all patients admitted for on- pump CABG and/or valve surgery
Able to give consent
Age > 18 years all patients admitted for on- pump CABG and/or valve surgery

Exclusion Criterias

Pregnant or lactating women
Chronic Renal failure (eGFR<30 ml/min/kg)
Allergies to excipients of IMP and placebo
...
Pregnant or lactating women
Chronic Renal failure (eGFR<30 ml/min/kg)
Allergies to excipients of IMP and placebo
Peripheral arterial disease
Severe liver disease

Summary

Conditions
Myocardial Reperfusion Injury
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Ischaemic heart disease is a leading cause of mortality in the western world. A number of patients undergo coronary artery bypass graft (CABG) surgery as treatment for ischaemic heart disease. With the rise of interventional procedures, patients who are coming to have CABG surgery are higher risk1. ...

Ischaemic heart disease is a leading cause of mortality in the western world. A number of patients undergo coronary artery bypass graft (CABG) surgery as treatment for ischaemic heart disease. With the rise of interventional procedures, patients who are coming to have CABG surgery are higher risk1. Remote ischaemic preconditioning (RIPC) has been shown to reduce perioperative myocardial injury (PMI) in patients having CABG even when cold blood cardioplegia or intermittent cross clamp fibrillation is used as cardioprotective measures. These patients have a general anaesthetic with multiple infusions including Glyceryl Trinitrate (GTN). The use of GTN in these patients is based on theoretical assumptions of coronary vasodilation pre operatively along with maintaining graft potency postoperatively. We intend to investigate the effect of GTN in patients undergoing cardiac surgery being subjected to RIPC in its role as a Nitric Oxide (NO) donor. Exogenous NO has been shown to be cardioprotective in animal models.

Inclusion Criterias

Able to give consent
Age > 18 years all patients admitted for on- pump CABG and/or valve surgery
Able to give consent
Age > 18 years all patients admitted for on- pump CABG and/or valve surgery

Exclusion Criterias

Pregnant or lactating women
Chronic Renal failure (eGFR<30 ml/min/kg)
Allergies to excipients of IMP and placebo
...
Pregnant or lactating women
Chronic Renal failure (eGFR<30 ml/min/kg)
Allergies to excipients of IMP and placebo
Peripheral arterial disease
Severe liver disease

Locations

London, NW1 2PG
London, NW1 2PG

Tracking Information

NCT #
NCT01864252
Collaborators
University College London Hospitals
Investigators
  • Principal Investigator: Derek Yellon, PhD DSc FRCP The Hatter Cardiovascular Institute
  • Derek Yellon, PhD DSc FRCP The Hatter Cardiovascular Institute