Effect of Remote Ischaemic Preconditioning on Clinical Outcomes in CABG Surgery
NCT ID: NCT01247545
Last Updated: 2015-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1612 participants
INTERVENTIONAL
2010-11-30
2015-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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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.
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.
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.
Remote ischaemic preconditioning
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.
Interventions
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Remote ischaemic preconditioning
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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Patients aged 18 years and above
3. Patients with an additive Euroscore greater than or equal to 5
Exclusion Criteria
2. Cardiac arrest on current admission
3. Pregnancy
4. Significant peripheral arterial disease affecting the upper limbs
5. Patients with significant hepatic dysfunction (Prothrombin\>2.0 ratio)
6. Patients with significant pulmonary disease (FEV1\<40% predicted)
7. Patients with known renal failure with a GFR\<30 mL/min/1.73 m2
8. Patients on glibenclamide or nicorandil, as these medications may interfere with RIC
9. Patients recruited into another study which may impact on the ERICCA study
18 Years
ALL
No
Sponsors
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University College, London
OTHER
Responsible Party
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Principal Investigators
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Derek J Hausenloy, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University College, London
Locations
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Essex Cardiothoracic Centre
Basildon, Essex, United Kingdom
Royal Sussex County Hospital
Brighton, Sussex, United Kingdom
Blackpool Victoria Hospital
Blackpool, , United Kingdom
Papworth Hospital
Cambridge, , United Kingdom
Cardiff & Vale University Health Board
Cardiff, , United Kingdom
Edinburgh Royal Infirmary
Edinburgh, , United Kingdom
Golden Jubilee Hospital
Glasgow, , United Kingdom
Harefield Hospital
Harefield, , United Kingdom
Castle Hill Hospital
Hull, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Kings College London Hospital
London, , United Kingdom
London Chest Hospital
London, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
St George's Hospital
London, , United Kingdom
St Thomas Hospital
London, , United Kingdom
UCLH Heart Hospital
London, , United Kingdom
John Radcliffe Hospital
Manchester, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
Trent Cardiac Centre
Nottingham, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Northern General Hospital
Sheffield, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Swansea Hospital
Swansea, , United Kingdom
Wolverhampton Hospital
Wolverhampton, , United Kingdom
Countries
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References
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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, 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.
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.
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.
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.
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.
Other Identifiers
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10/0303
Identifier Type: -
Identifier Source: org_study_id
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