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Investigation Into the Role of GTN & RIPC in Cardiac Surgery

Information source: University College, London
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myocardial Reperfusion Injury

Intervention: Remote ischaemic preconditioning (Other); IV Normal saline (Drug); IV Glyceryl trinitrate 2-5ml/h (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University College, London

Official(s) and/or principal investigator(s):
Derek Yellon, PhD DSc FRCP, Principal Investigator, Affiliation: The Hatter Cardiovascular Institute

Overall contact:
Derek M Yellon, PhD DSC FACC, Phone: 02034479888, Email: D.Yellon@ucl.ac.uk


The purpose of this study is to determine whether Glyceryl Trinitrate (GTN) reduces injury to the heart during heart-lung bypass surgery in combination with the newer technique of remote ischaemic preconditioning (RIPC).

Clinical Details

Official title: The Effect of Remote Ischaemic Preconditioning and Glyceryl Trinitrate on Peri-operative Myocardial Injury in Cardiac Bypass Surgery Patients (ERIC-GTN Study)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Troponin T area under the curve

Secondary outcome:

Inotrope/Vasopressor requirements peri-operatively

Ventilator dependence post operatively

Incidence of Acute Kidney Injury assessed using biomarkers

Length of ITU stay

Length of hospital stay

Incidence of post-operative atrial fibrillation

Detailed 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. 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

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

- Able to give consent

Exclusion Criteria:

- Allergies to excipients of IMP and placebo

- Chronic Renal failure (eGFR<30 ml/min/kg)

- Severe liver disease

- Peripheral arterial disease

- Pregnant or lactating women

Locations and Contacts

Derek M Yellon, PhD DSC FACC, Phone: 02034479888, Email: D.Yellon@ucl.ac.uk

The Heart Hospital, UCL Hospitals NHS Trust, London NW1 2PG, United Kingdom; Recruiting
Ashraf Hamarneh, MBchB,MRCP, Phone: 02034479781, Email: a.hamarneh@ucl.ac.uk
Derek M Yellon, PhD DSc FACC, Principal Investigator
Derek J Hausenloy, MD PhD FRCP, Principal Investigator
Ashraf Hamarneh, MBchB MRCP, Sub-Investigator
Shyam Kolvekar, MS MCh FRCS, Sub-Investigator
Roger Cordery, BSc FRCA, Sub-Investigator
Vivek Sivaraman, MRCP MD FRCA, Sub-Investigator
Additional Information

Starting date: January 2014
Last updated: July 7, 2015

Page last updated: August 23, 2015

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