Effect of Remote Ischaemic Preconditioning on Clinical Outcomes in CABG Surgery (ERICCA)
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.
研究概览
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Blackpool、英国
- Blackpool Victoria Hospital
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Cambridge、英国
- Papworth Hospital
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Cardiff、英国
- Cardiff & Vale University Health Board
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Edinburgh、英国
- Edinburgh Royal Infirmary
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Glasgow、英国
- Golden Jubilee Hospital
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Harefield、英国
- Harefield Hospital
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Hull、英国
- Castle Hill Hospital
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Leicester、英国
- Glenfield Hospital
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London、英国
- Royal Brompton Hospital
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London、英国
- St George's Hospital
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London、英国
- Hammersmith Hospital
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London、英国
- St Bartholomew's Hospital
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London、英国
- St Thomas Hospital
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London、英国
- Kings College London Hospital
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London、英国
- London Chest Hospital
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London、英国
- UCLH Heart Hospital
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Manchester、英国
- Manchester Royal Infirmary
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Manchester、英国
- Wythenshawe Hospital
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Manchester、英国
- John Radcliffe Hospital
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Newcastle、英国
- Freeman Hospital
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Nottingham、英国
- Trent Cardiac Centre
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Plymouth、英国
- Derriford Hospital
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Sheffield、英国
- Northern General Hospital
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Southampton、英国
- Southampton General Hospital
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Swansea、英国
- Swansea Hospital
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Wolverhampton、英国
- Wolverhampton Hospital
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Essex
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Basildon、Essex、英国
- Essex cardiothoracic centre
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Sussex
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Brighton、Sussex、英国
- Royal Sussex County Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients undergoing CABG with or without valve surgery using blood cardioplegia
- Patients aged 18 years and above
- Patients with an additive Euroscore greater than or equal to 5
Exclusion Criteria:
- Cardiogenic shock
- Cardiac arrest on current admission
- Pregnancy
- Significant peripheral arterial disease affecting the upper limbs
- Patients with significant hepatic dysfunction (Prothrombin>2.0 ratio)
- Patients with significant pulmonary disease (FEV1<40% predicted)
- Patients with known renal failure with a GFR<30 mL/min/1.73 m2
- Patients on glibenclamide or nicorandil, as these medications may interfere with RIC
- Patients recruited into another study which may impact on the ERICCA study
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较：Control
Control treatment (sham RIC) will consist of four 5-minute simulated inflations of a blood pressure cuff placed on the upper arm.
The inflations will be separated by 5-minute periods when the blood pressure cuff will be deflated.
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Control treatment (sham RIC) will consist of four 5-minute simulated inflations of a blood pressure cuff placed on the upper arm.
The inflations will be separated by 5-minute periods when the blood pressure cuff will be deflated.
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有源比较器：Remote ischaemic conditioning
Blood pressure cuff placed on upper arm and inflated to 200mmHg for 5 minutes then deflated for 5 minutes - this cycle is repeated a total of 4 times.
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Blood pressure cuff placed on upper arm and inflated to 200mmHg for 5 minutes then deflated for 5 minutes - this cycle is repeated a total of 4 times.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Major adverse cardiac and cerebral events
大体时间：One year post-surgery
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Combined endpoint of Cardiovascular death, MI, Revascularisation and Stroke.
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One year post-surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Peri-operative myocardial injury
大体时间：72 hours peri-operative period
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72 hours area under curve serum troponin-T
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72 hours peri-operative period
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LV ejection fraction
大体时间：At one year
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Echo determined LV ejection fraction
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At one year
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Acute kidney injury
大体时间：Peri-operative
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Acute kidney injury score and 24 hour area under curve serum NGAL
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Peri-operative
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30 day MACCE
大体时间：30 days post surgery
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Major adverse cardiac and cerebral events 30 days post surgery
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30 days post surgery
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All cause death
大体时间：1 year post surgery
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1 year post surgery
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Length of ITU stay
大体时间：ITU stay
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ITU stay
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Length of hospital stay
大体时间：Until hospital discharge
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Until hospital discharge
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Inotrope score
大体时间：72 hours post surgery
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Inotrope score after 72 hours
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72 hours post surgery
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6 minute Walk Test
大体时间：6 weeks and 12 months post surgery
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6 weeks and 12 months post surgery
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Quality of Life
大体时间：6 weeks, 3/6/9 and 12 months post surgery
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Quality of Life assessed using the EQ-5D measurement
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6 weeks, 3/6/9 and 12 months post surgery
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合作者和调查者
调查人员
- 首席研究员：Derek J Hausenloy, MD PhD、University College, London
出版物和有用的链接
一般刊物
- Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.
- Venugopal V, Laing CM, Ludman A, Yellon DM, Hausenloy D. Effect of remote ischemic preconditioning on acute kidney injury in nondiabetic patients undergoing coronary artery bypass graft surgery: a secondary analysis of 2 small randomized trials. Am J Kidney Dis. 2010 Dec;56(6):1043-9. doi: 10.1053/j.ajkd.2010.07.014. Epub 2010 Oct 25.
- Hausenloy DJ, Yellon DM. Remote ischaemic preconditioning: underlying mechanisms and clinical application. Cardiovasc Res. 2008 Aug 1;79(3):377-86. doi: 10.1093/cvr/cvn114. Epub 2008 May 2.
- Candilio L, Malik A, Ariti C, Barnard M, Di Salvo C, Lawrence D, Hayward M, Yap J, Roberts N, Sheikh A, Kolvekar S, Hausenloy DJ, Yellon DM. Effect of remote ischaemic preconditioning on clinical outcomes in patients undergoing cardiac bypass surgery: a randomised controlled clinical trial. Heart. 2015 Feb;101(3):185-92. doi: 10.1136/heartjnl-2014-306178. Epub 2014 Sep 24.
- Venugopal V, Hausenloy DJ, Ludman A, Di Salvo C, Kolvekar S, Yap J, Lawrence D, Bognolo J, Yellon DM. Remote ischaemic preconditioning reduces myocardial injury in patients undergoing cardiac surgery with cold-blood cardioplegia: a randomised controlled trial. Heart. 2009 Oct;95(19):1567-71. doi: 10.1136/hrt.2008.155770. Epub 2009 Jun 8.
- Hausenloy DJ, Candilio L, Evans R, Ariti C, Jenkins DP, Kolvekar S, Knight R, Kunst G, Laing C, Nicholas J, Pepper J, Robertson S, Xenou M, Clayton T, Yellon DM; ERICCA Trial Investigators. Remote Ischemic Preconditioning and Outcomes of Cardiac Surgery. N Engl J Med. 2015 Oct 8;373(15):1408-17. doi: 10.1056/NEJMoa1413534. Epub 2015 Oct 5.
- Hausenloy DJ, Candilio L, Laing C, Kunst G, Pepper J, Kolvekar S, Evans R, Robertson S, Knight R, Ariti C, Clayton T, Yellon DM; ERICCA Trial Investigators. 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. 2012 May;101(5):339-48. doi: 10.1007/s00392-011-0397-x. Epub 2011 Dec 21.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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