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Effect of Remote Ischaemic Preconditioning on Clinical Outcomes in CABG Surgery (ERICCA)

28. maj 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1612

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
      • Blackpool, Det Forenede Kongerige
        • Blackpool Victoria Hospital
      • Cambridge, Det Forenede Kongerige
        • Papworth Hospital
      • Cardiff, Det Forenede Kongerige
        • Cardiff & Vale University Health Board
      • Edinburgh, Det Forenede Kongerige
        • Edinburgh Royal Infirmary
      • Glasgow, Det Forenede Kongerige
        • Golden Jubilee Hospital
      • Harefield, Det Forenede Kongerige
        • Harefield Hospital
      • Hull, Det Forenede Kongerige
        • Castle Hill Hospital
      • Leicester, Det Forenede Kongerige
        • Glenfield Hospital
      • London, Det Forenede Kongerige
        • Royal Brompton Hospital
      • London, Det Forenede Kongerige
        • St George's Hospital
      • London, Det Forenede Kongerige
        • Hammersmith Hospital
      • London, Det Forenede Kongerige
        • St Bartholomew's Hospital
      • London, Det Forenede Kongerige
        • St Thomas Hospital
      • London, Det Forenede Kongerige
        • Kings College London Hospital
      • London, Det Forenede Kongerige
        • London Chest Hospital
      • London, Det Forenede Kongerige
        • UCLH Heart Hospital
      • Manchester, Det Forenede Kongerige
        • Manchester Royal Infirmary
      • Manchester, Det Forenede Kongerige
        • Wythenshawe Hospital
      • Manchester, Det Forenede Kongerige
        • John Radcliffe Hospital
      • Newcastle, Det Forenede Kongerige
        • Freeman Hospital
      • Nottingham, Det Forenede Kongerige
        • Trent Cardiac Centre
      • Plymouth, Det Forenede Kongerige
        • Derriford Hospital
      • Sheffield, Det Forenede Kongerige
        • Northern General Hospital
      • Southampton, Det Forenede Kongerige
        • Southampton General Hospital
      • Swansea, Det Forenede Kongerige
        • Swansea Hospital
      • Wolverhampton, Det Forenede Kongerige
        • Wolverhampton Hospital
    • Essex
      • Basildon, Essex, Det Forenede Kongerige
        • Essex Cardiothoracic Centre
    • Sussex
      • Brighton, Sussex, Det Forenede Kongerige
        • Royal Sussex County Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Patients undergoing CABG with or without valve surgery using blood cardioplegia
  2. Patients aged 18 years and above
  3. Patients with an additive Euroscore greater than or equal to 5

Exclusion Criteria:

  1. Cardiogenic shock
  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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
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.
Procedure: 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.
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.
Procedure: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Major adverse cardiac and cerebral events
Tidsramme: One year post-surgery
Combined endpoint of Cardiovascular death, MI, Revascularisation and Stroke.
One year post-surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Peri-operative myocardial injury
Tidsramme: 72 hours peri-operative period
72 hours area under curve serum troponin-T
72 hours peri-operative period
LV ejection fraction
Tidsramme: At one year
Echo determined LV ejection fraction
At one year
Acute kidney injury
Tidsramme: Peri-operative
Acute kidney injury score and 24 hour area under curve serum NGAL
Peri-operative
30 day MACCE
Tidsramme: 30 days post surgery
Major adverse cardiac and cerebral events 30 days post surgery
30 days post surgery
All cause death
Tidsramme: 1 year post surgery
1 year post surgery
Length of ITU stay
Tidsramme: ITU stay
ITU stay
Length of hospital stay
Tidsramme: Until hospital discharge
Until hospital discharge
Inotrope score
Tidsramme: 72 hours post surgery
Inotrope score after 72 hours
72 hours post surgery
6 minute Walk Test
Tidsramme: 6 weeks and 12 months post surgery
6 weeks and 12 months post surgery
Quality of Life
Tidsramme: 6 weeks, 3/6/9 and 12 months post surgery
Quality of Life assessed using the EQ-5D measurement
6 weeks, 3/6/9 and 12 months post surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University College, London

Efterforskere

  • Ledende efterforsker: Derek J Hausenloy, MD PhD, University College, London

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2010

Primær færdiggørelse (Faktiske)

1. marts 2015

Studieafslutning (Faktiske)

1. marts 2015

Datoer for studieregistrering

Først indsendt

22. november 2010

Først indsendt, der opfyldte QC-kriterier

23. november 2010

Først opslået (Skøn)

24. november 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. maj 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2015

Sidst verificeret

1. maj 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 10/0303

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