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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01247545
First Posted: November 24, 2010
Last Update Posted: May 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University College, London
  Purpose

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.


Condition Intervention Phase
Coronary Heart Disease Procedure: Remote ischaemic preconditioning Procedure: Control Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Remote Ischaemic Preconditioning on Clinical Outcomes in Coronary Artery Bypass Graft Surgery

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Major adverse cardiac and cerebral events [ Time Frame: One year post-surgery ]
    Combined endpoint of Cardiovascular death, MI, Revascularisation and Stroke.


Secondary Outcome Measures:
  • Peri-operative myocardial injury [ Time Frame: 72 hours peri-operative period ]
    72 hours area under curve serum troponin-T

  • LV ejection fraction [ Time Frame: At one year ]
    Echo determined LV ejection fraction

  • Acute kidney injury [ Time Frame: Peri-operative ]
    Acute kidney injury score and 24 hour area under curve serum NGAL

  • 30 day MACCE [ Time Frame: 30 days post surgery ]
    Major adverse cardiac and cerebral events 30 days post surgery

  • All cause death [ Time Frame: 1 year post surgery ]
  • Length of ITU stay [ Time Frame: ITU stay ]
  • Length of hospital stay [ Time Frame: Until hospital discharge ]
  • Inotrope score [ Time Frame: 72 hours post surgery ]
    Inotrope score after 72 hours

  • 6 minute Walk Test [ Time Frame: 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


Enrollment: 1612
Study Start Date: November 2010
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247545


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01247545     History of Changes
Other Study ID Numbers: 10/0303
First Submitted: November 22, 2010
First Posted: November 24, 2010
Last Update Posted: May 29, 2015
Last Verified: May 2015

Keywords provided by University College, London:
Remote ischemic preconditioning
Coronary artery bypass graft surgery
Cardioprotection
Clinical Outcomes

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases