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Coronary Heart DiseasePhase 3ERICCANCT01247545

Effect of Remote Ischaemic Preconditioning on Clinical Outcomes in CABG Surgery

A Phase 3 study testing Remote ischaemic preconditioning in people with Coronary Heart Disease, run by University College, London at 28 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Heart Disease
What is being tested?
Remote ischaemic preconditioning
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,612 participants
Where
28 sitesUnited Kingdom
Study dates
Nov 2010to Mar 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

United Kingdom28 sites

  • Essex Cardiothoracic Centre

    Basildon, Essex

  • Blackpool Victoria Hospital

    Blackpool

  • Royal Sussex County Hospital

    Brighton, Sussex

  • Papworth Hospital

    Cambridge

  • Cardiff & Vale University Health Board

    Cardiff

  • Edinburgh Royal Infirmary

    Edinburgh

  • Golden Jubilee Hospital

    Glasgow

  • Harefield Hospital

    Harefield

  • Castle Hill Hospital

    Hull

  • Glenfield Hospital

    Leicester

  • Hammersmith Hospital

    London

  • Kings College London Hospital

    London

  • London Chest Hospital

    London

  • Royal Brompton Hospital

    London

  • St Bartholomew's Hospital

    London

  • St George's Hospital

    London

  • St Thomas Hospital

    London

  • UCLH Heart Hospital

    London

  • John Radcliffe Hospital

    Manchester

  • Manchester Royal Infirmary

    Manchester

  • Wythenshawe Hospital

    Manchester

  • Freeman Hospital

    Newcastle

  • Trent Cardiac Centre

    Nottingham

  • Derriford Hospital

    Plymouth

  • Northern General Hospital

    Sheffield

  • Southampton General Hospital

    Southampton

  • Swansea Hospital

    Swansea

  • Wolverhampton Hospital

    Wolverhampton

Other trials in United Kingdom

About this study

Official title: 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.

Being tested
Remote ischaemic preconditioning, Control
Keywords
Remote ischemic preconditioning, Coronary artery bypass graft surgery, Cardioprotection, Clinical Outcomes
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote ischaemic preconditioningProcedure or surgery

    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.

  • ControlProcedure or surgery

    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.

Study groups in NCT01247545
Study groupRoleWhat they receive
ControlPlacebo comparatorControl 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.
Receives: Procedure: Control
Remote ischaemic conditioningActive comparatorBlood 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.
Receives: Procedure: Remote ischaemic preconditioning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major adverse cardiac and cerebral events

    Combined endpoint of Cardiovascular death, MI, Revascularisation and Stroke.

    Measured: One year post-surgery

Secondary outcomes (10)

  1. Peri-operative myocardial injury

    72 hours area under curve serum troponin-T

    Measured: 72 hours peri-operative period

  2. LV ejection fraction

    Echo determined LV ejection fraction

    Measured: At one year

  3. Acute kidney injury

    Acute kidney injury score and 24 hour area under curve serum NGAL

    Measured: Peri-operative

  4. 30 day MACCE

    Major adverse cardiac and cerebral events 30 days post surgery

    Measured: 30 days post surgery

  5. All cause death

    Measured: 1 year post surgery

  6. Length of ITU stay

    Measured: ITU stay

  7. Length of hospital stay

    Measured: Until hospital discharge

  8. Inotrope score

    Inotrope score after 72 hours

    Measured: 72 hours post surgery

  9. 6 minute Walk Test

    Measured: 6 weeks and 12 months post surgery

  10. Quality of Life

    Quality of Life assessed using the EQ-5D measurement

    Measured: 6 weeks, 3/6/9 and 12 months post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,612 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01247545
Sponsor's protocol ID
10/0303
Acronym
ERICCA
Status last verified
May 2015
First submitted
22 Nov 2010
Last updated
29 May 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17707752

  • 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.

    PubMed 19508973

  • 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.

    PubMed 20974511

  • 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.

    PubMed 18456674

  • 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.

    PubMed 26436207

  • 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.

    PubMed 25252696

  • 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.

    PubMed 22186969

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remote ischaemic preconditioning in people with Coronary Heart Disease, run by University College, London at 28 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse cardiac and cerebral events (time frame: One year post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01247545, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2015.

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