Coronary Heart Disease Clinical Trial
Official title:
Effect of Remote Ischaemic Preconditioning on Clinical Outcomes in Coronary Artery Bypass Graft Surgery
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 £7.9 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
with or without valve (CABG±valve) surgery.
The hypothesis tested in this research proposal is that 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, improves 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 28 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 the investigators pilot studies to reduce damage to the heart muscle by up to 40% during
CABG±valve surgery. The investigators 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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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