- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01247545
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Blackpool, Regno Unito
- Blackpool Victoria Hospital
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Cambridge, Regno Unito
- Papworth Hospital
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Cardiff, Regno Unito
- Cardiff & Vale University Health Board
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Edinburgh, Regno Unito
- Edinburgh Royal Infirmary
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Glasgow, Regno Unito
- Golden Jubilee Hospital
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Harefield, Regno Unito
- Harefield Hospital
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Hull, Regno Unito
- Castle Hill Hospital
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Leicester, Regno Unito
- Glenfield Hospital
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London, Regno Unito
- Royal Brompton Hospital
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London, Regno Unito
- St George's Hospital
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London, Regno Unito
- Hammersmith Hospital
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London, Regno Unito
- St Bartholomew'S Hospital
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London, Regno Unito
- St Thomas Hospital
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London, Regno Unito
- Kings College London Hospital
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London, Regno Unito
- London Chest Hospital
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London, Regno Unito
- UCLH Heart Hospital
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Manchester, Regno Unito
- Manchester Royal Infirmary
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Manchester, Regno Unito
- Wythenshawe Hospital
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Manchester, Regno Unito
- John Radcliffe Hospital
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Newcastle, Regno Unito
- Freeman Hospital
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Nottingham, Regno Unito
- Trent Cardiac Centre
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Plymouth, Regno Unito
- Derriford Hospital
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Sheffield, Regno Unito
- Northern General Hospital
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Southampton, Regno Unito
- Southampton General Hospital
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Swansea, Regno Unito
- Swansea Hospital
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Wolverhampton, Regno Unito
- Wolverhampton Hospital
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Essex
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Basildon, Essex, Regno Unito
- Essex Cardiothoracic Centre
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Sussex
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Brighton, Sussex, Regno Unito
- Royal Sussex County Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore placebo: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Major adverse cardiac and cerebral events
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Peri-operative myocardial injury
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 1 year post surgery
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1 year post surgery
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Length of ITU stay
Lasso di tempo: ITU stay
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ITU stay
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Length of hospital stay
Lasso di tempo: Until hospital discharge
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Until hospital discharge
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Inotrope score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Derek J Hausenloy, MD PhD, University College, London
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 10/0303
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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