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

May 28, 2015 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1612

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Active Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac and cerebral events
Time Frame: One year post-surgery
Combined endpoint of Cardiovascular death, MI, Revascularisation and Stroke.
One year post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-operative myocardial injury
Time Frame: 72 hours peri-operative period
72 hours area under curve serum troponin-T
72 hours peri-operative period
LV ejection fraction
Time Frame: At one year
Echo determined LV ejection fraction
At one year
Acute kidney injury
Time Frame: Peri-operative
Acute kidney injury score and 24 hour area under curve serum NGAL
Peri-operative
30 day MACCE
Time Frame: 30 days post surgery
Major adverse cardiac and cerebral events 30 days post surgery
30 days post surgery
All cause death
Time Frame: 1 year post surgery
1 year post surgery
Length of ITU stay
Time Frame: ITU stay
ITU stay
Length of hospital stay
Time Frame: Until hospital discharge
Until hospital discharge
Inotrope score
Time Frame: 72 hours post surgery
Inotrope score after 72 hours
72 hours post surgery
6 minute Walk Test
Time Frame: 6 weeks and 12 months post surgery
6 weeks and 12 months post surgery
Quality of Life
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Investigators

  • Principal Investigator: Derek J Hausenloy, MD PhD, University College, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

November 22, 2010

First Submitted That Met QC Criteria

November 23, 2010

First Posted (Estimate)

November 24, 2010

Study Record Updates

Last Update Posted (Estimate)

May 29, 2015

Last Update Submitted That Met QC Criteria

May 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/0303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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