Effect of Remote Ischaemic preConditioning on Clinical outcomes in patients undergoing Coronary Artery bypass graft surgery (ERICCA study): A multicentre double-blind randomised controlled clinical trial

Coronary heart disease (CHD) is the leading cause of death in the UK, accounting for 124,000 deaths (2006) and costing the UK economy over £79 billion a year Patients with severe CHD are usually treated by coronary artery bypass graft (CABG) surgery, the risks of which are increasing due to older and sicker patients being operated on New treatment strategies are therefore required to improve health outcomes in these high-risk patients undergoing CABG surgery with or without valve (CABG±valve) surgery The objective of this research proposal is to determine whether remote ischaemic preconditioning (RIC), a virtually cost-free, non-pharmacological and simple non-invasive strategy for reducing the damage to the heart muscle at the time of surgery, can improve health outcomes in high-risk patients undergoing CABG±valve surgery In this research project, 1610 high-risk patients undergoing CABG±valve surgery will be recruited via 9 UK hospitals performing heart surgery Patients will be randomly allocated to receive either RIC or control For RIC, a blood pressure cuff will be placed on the upper arm to temporarily deprive it of oxygen and nutrients, an intervention which has been shown in our pilot studies to reduce damage to the heart muscle by up to 40% during CABG±valve surgery We will determine whether RIC can improve health outcomes in terms of better patient survival, less heart attacks and strokes, shorter hospital stay; less damage to the heart, kidney and brain during surgery; better heart function post-surgery and less chance of developing heart failure; better exercise tolerance and quality of life This trial will bring together a multi-disciplinary team of investigators each with complementary skills and expertise in the design, running and analysis of the study: heart research scientists, cardiologists, cardiac surgeons, kidney specialists, cardiac anaesthetists, research nurses, clinical trials experts, a database manager, statisticians, and two previous heart bypass surgery patients The main costs of the research study will be for research nurses to recruit and collect data, the co-ordination of the study, statistical support and analysis using an experienced Clinical Trials Unit and for blood tests to measure the beneficial effects of RIC on the heart and kidney Our research study will be integrated into usual clinical practice wherever possible, in order to keep down costs