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Effect of remote ischemic preconditioning on clinical outcomes in patients undergoing coronary artery bypass graft surgery (ERICCA): rationale and study design of a multi-centre randomized double-blinded controlled clinical trial

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Abstract

Background

Novel cardioprotective strategies are required to improve clinical outcomes in high risk patients undergoing coronary artery bypass graft (CABG) ± valve surgery. Remote ischemic preconditioning (RIC), in which brief episodes of non-lethal ischemia and reperfusion are applied to the arm or leg, has been demonstrated to reduce perioperative myocardial injury following CABG ± valve surgery. Whether RIC can improve clinical outcomes in this setting is unknown and is investigated in the effect of remote ischemic preconditioning on clinical outcomes (ERICCA) trial in patients undergoing CABG surgery. (ClinicalTrials.gov Identifier: NCT01247545).

Methods

The ERICCA trial is a multicentre randomized double-blinded controlled clinical trial which will recruit 1,610 high-risk patients (Additive Euroscore ≥ 5) undergoing CABG ± valve surgery using blood cardioplegia via 27 tertiary centres over 2 years. The primary combined endpoint will be cardiovascular death, non-fatal myocardial infarction, coronary revascularization and stroke at 1 year. Secondary endpoints will include peri-operative myocardial and acute kidney injury, intensive care unit and hospital stay, inotrope score, left ventricular ejection fraction, changes of quality of life and exercise tolerance. Patients will be randomized to receive after induction of anesthesia either RIC (4 cycles of 5 min inflation to 200 mmHg and 5 min deflation of a blood pressure cuff placed on the upper arm) or sham RIC (4 cycles of simulated inflations and deflations of the blood pressure cuff).

Implications

The findings from the ERICCA trial have the potential to demonstrate that RIC, a simple, non-invasive and virtually cost-free intervention, can improve clinical outcomes in higher-risk patients undergoing CABG ± valve surgery.

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Acknowledgments

We are extremely grateful to the National Institute of Health Research, the Medical Research Council and the British Heart Foundation who have kindly agreed to fund the ERICCA trial with an Efficacy and Mechanism Evaluation research grant: Reference number 09/100/05. The Efficacy and Mechanism Evaluation programme is funded by the MRC and NIHR and managed by the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the MRC, NHS, NIHR or the Department of Health.

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Authors and Affiliations

  1. The Hatter Cardiovascular Institute, University College London, 67 Chenies Mews, London, WC1E 6HX, UK

    Derek J. Hausenloy, Luciano Candilio & Derek M. Yellon

  2. Royal Free Hospital, London, UK

    Chris Laing

  3. Kings College London, London, UK

    Gudrun Kunst

  4. Royal Brompton Hospital, London, UK

    John Pepper

  5. The Heart Hospital, University College London Hospitals, London, UK

    Shyam Kolvekar

  6. Clinical Trials Unit, London School of Hygiene and Tropical Medicine, London, UK

    Richard Evans, Steve Robertson, Rosemary Knight, Cono Ariti & Tim Clayton

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  1. Derek J. Hausenloy
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  2. Luciano Candilio
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  4. Gudrun Kunst
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  12. Derek M. Yellon
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The ERICCA Trial Investigators

Corresponding author

Correspondence to Derek M. Yellon.

Additional information

D. J. Hausenloy and L. Candilio are joint first authors.

Research collaborators

Research collaborators

Mr. Geoff Berg, Golden Jubilee Hospital, Mr. Moninder Bhabra, Wolverhampton Hospital, New Cross Hospital, Mr. Chris Blauth, St Thomas’ Hospital, Mr. Norman Briffa, Northern General Hospital, Prof. John Dark, The Freeman Hospital, Mr. Jatin Desai, Kings College London Hospital, Mr. Steven Griffin, Castle Hill Hospital, Marjan Jahangiri, St George’s Hospital, Mr. David Jenkins, Papworth Hospital, Prof. Daniel Keenan, Manchester Royal Infirmary, Mr. Shyam Kolvekar, Heart Hospital, Mr. Dheeraj Mehta, Cardiff University Hosptial, Prof. John Pepper, Royal Brompton Hospital, Mr. Renzo Pessotto, Edinburgh Royal Infirmary, Mr. Mario Petrou, John Radcliffe Hospital, Mr. Prakash Punjabi, Hammersmith Hospital, Mr. David Richens, Trent Cardiac Centre, Mr. Andrew Ritchie, Essex Cardiothoracic Centre, Mr. André Simon, Harefield Hospital, Prof. Tom Spyt, Glenfield Hospital, Mr. Augustine Tang, Blackpool Victoria Hospital, Mr. Uday Trivedi, Royal Sussex County Hospital, Mr. Jonathan Unsworth-White, Derriford Hospital, Mr. Rakesh Uppal, London Chest Hospital and St Barts’ Hospital, Prof. Nizar Yonan, Wythenshawe Hospital, Mr. Aprim Youhana, Morriston Hospital.

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Hausenloy, D.J., Candilio, L., Laing, C. et al. Effect of remote ischemic preconditioning on clinical outcomes in patients undergoing coronary artery bypass graft surgery (ERICCA): rationale and study design of a multi-centre randomized double-blinded controlled clinical trial. Clin Res Cardiol 101, 339–348 (2012). https://doi.org/10.1007/s00392-011-0397-x

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