Effect of Remote Ischaemic Preconditioning on Clinical Outcomes in CABG Surgery (ERICCA)
28. mai 2015 oppdatert av: University College, London
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
1612
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Blackpool, Storbritannia
- Blackpool Victoria Hospital
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Cambridge, Storbritannia
- Papworth Hospital
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Cardiff, Storbritannia
- Cardiff & Vale University Health Board
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Edinburgh, Storbritannia
- Edinburgh Royal Infirmary
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Glasgow, Storbritannia
- Golden Jubilee Hospital
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Harefield, Storbritannia
- Harefield Hospital
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Hull, Storbritannia
- Castle Hill Hospital
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Leicester, Storbritannia
- Glenfield Hospital
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London, Storbritannia
- Royal Brompton Hospital
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London, Storbritannia
- St George's Hospital
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London, Storbritannia
- Hammersmith Hospital
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London, Storbritannia
- St Bartholomew's Hospital
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London, Storbritannia
- St Thomas Hospital
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London, Storbritannia
- Kings College London Hospital
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London, Storbritannia
- London Chest Hospital
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London, Storbritannia
- UCLH Heart Hospital
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Manchester, Storbritannia
- Manchester Royal Infirmary
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Manchester, Storbritannia
- Wythenshawe Hospital
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Manchester, Storbritannia
- John Radcliffe Hospital
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Newcastle, Storbritannia
- Freeman Hospital
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Nottingham, Storbritannia
- Trent Cardiac Centre
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Plymouth, Storbritannia
- Derriford Hospital
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Sheffield, Storbritannia
- Northern General Hospital
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Southampton, Storbritannia
- Southampton General Hospital
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Swansea, Storbritannia
- Swansea Hospital
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Wolverhampton, Storbritannia
- Wolverhampton Hospital
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Essex
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Basildon, Essex, Storbritannia
- Essex cardiothoracic centre
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Sussex
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Brighton, Sussex, Storbritannia
- Royal Sussex County Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Placebo komparator: 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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Aktiv komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Major adverse cardiac and cerebral events
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Peri-operative myocardial injury
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 year post surgery
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1 year post surgery
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Length of ITU stay
Tidsramme: ITU stay
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ITU stay
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Length of hospital stay
Tidsramme: Until hospital discharge
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Until hospital discharge
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Inotrope score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Derek J Hausenloy, MD PhD, University College, London
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2010
Primær fullføring (Faktiske)
1. mars 2015
Studiet fullført (Faktiske)
1. mars 2015
Datoer for studieregistrering
Først innsendt
22. november 2010
Først innsendt som oppfylte QC-kriteriene
23. november 2010
Først lagt ut (Anslag)
24. november 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
29. mai 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. mai 2015
Sist bekreftet
1. mai 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 10/0303
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