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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01247545
First received: November 22, 2010
Last updated: October 22, 2014
Last verified: October 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
    Combined endpoint of Cardiovascular death, MI, Revascularisation and Stroke.


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

  • LV ejection fraction [ Time Frame: At one year ] [ Designated as safety issue: No ]
    Echo determined LV ejection fraction

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

  • 30 day MACCE [ Time Frame: 30 days post surgery ] [ Designated as safety issue: Yes ]
    Major adverse cardiac and cerebral events 30 days post surgery

  • All cause death [ Time Frame: 1 year post surgery ] [ Designated as safety issue: Yes ]
  • Length of ITU stay [ Time Frame: ITU stay ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: Until hospital discharge ] [ Designated as safety issue: No ]
  • Inotrope score [ Time Frame: 72 hours post surgery ] [ Designated as safety issue: No ]
    Inotrope score after 72 hours

  • 6 minute Walk Test [ Time Frame: 6 weeks and 12 months post surgery ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 6 weeks, 3/6/9 and 12 months post surgery ] [ Designated as safety issue: No ]
    Quality of Life assessed using the EQ-5D measurement


Estimated Enrollment: 1610
Study Start Date: November 2010
Estimated Study Completion Date: March 2015
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Kings College London Hospital
London, United Kingdom
UCLH Heart 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
Hammersmith 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:
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01247545     History of Changes
Other Study ID Numbers: 10/0303
Study First Received: November 22, 2010
Last Updated: October 22, 2014
Health Authority: United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 20, 2014