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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University College, London.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01247545
First received: November 22, 2010
Last updated: January 9, 2012
Last verified: January 2012
  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: October 2013
Estimated Primary Completion Date: April 2013 (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

Contacts
Contact: Derek J Hausenloy, MD PhD +44 207 380 9888 d.hausenloy@ucl.ac.uk
Contact: Rosemary Knight +44(0)20 7927 2473 rosemary.knight@lshtm.ac.uk

Locations
United Kingdom
Essex Cardiothoracic Centre Recruiting
Basildon, Essex, United Kingdom
Contact: Andrew Ritchie, FRCS         
Principal Investigator: Andrew Ritchie, FRCS         
Royal Sussex County Hospital Recruiting
Brighton, Sussex, United Kingdom
Contact: Uday Trivedi, FRCS         
Principal Investigator: Uday Trivedi, FRCS         
Blackpool Victoria Hospital Not yet recruiting
Blackpool, United Kingdom
Contact: Augustine Tang         
Principal Investigator: Augustine Tang         
Papworth Hospital Recruiting
Cambridge, United Kingdom
Contact: David Jenkins         
Principal Investigator: David Jenkins, FRCS         
Cardiff & Vale University Health Board Not yet recruiting
Cardiff, United Kingdom
Contact: Dheeraj Mehta         
Principal Investigator: Dheeraj Mehta         
Edinburgh Royal Infirmary Not yet recruiting
Edinburgh, United Kingdom
Contact: Renzo Pessotto         
Principal Investigator: Renzo Pessotto         
Golden Jubilee Hospital Recruiting
Glasgow, United Kingdom
Contact: Geoff Berg         
Principal Investigator: Geoff Berg         
Harefield Hospital Not yet recruiting
Harefield, United Kingdom
Contact: John Pepper         
Principal Investigator: John Pepper         
Castle Hill Hospital Not yet recruiting
Hull, United Kingdom
Contact: Steven Griffin         
Principal Investigator: Steven Griffin         
Glenfield Hospital Not yet recruiting
Leicester, United Kingdom
Contact: Tom Spyt         
Principal Investigator: Tom Spyt         
Hammersmith Hospital Recruiting
London, United Kingdom
Contact: Prakash Punjabi, FRCS         
Principal Investigator: Prakash Punjabi, FRCS         
Royal Brompton Hospital Recruiting
London, United Kingdom
Contact: John Pepper, FRCS         
Principal Investigator: John Pepper, FRCS         
Kings College London Hospital Recruiting
London, United Kingdom
Contact: Jatin Desai, FRCS         
Principal Investigator: Jatin Desai, FRCS         
London Chest Hospital Not yet recruiting
London, United Kingdom
Contact: Rakesh Uppal, FRCS         
Principal Investigator: Rakesh Uppal, FRCS         
UCLH Heart Hospital Recruiting
London, United Kingdom
Contact: Luciano Candilio, MRCP    +44 (0)20 7380 9888    luciano2108@hotmail.com   
Principal Investigator: Shyam Kolvekar, FRCS         
St Thomas Hospital Recruiting
London, United Kingdom
Principal Investigator: Christopher Blauth, FRCS         
St George's Hospital Not yet recruiting
London, United Kingdom
Contact: Marhan Jahangiri, FRCS         
Principal Investigator: Marhan Jahangiri, FRCS         
St Bartholomew's Hospital Not yet recruiting
London, United Kingdom
Contact: Rakesh Uppal, FRCS         
Principal Investigator: Rakesh Uppal, FRCS         
Wythenshawe Hospital Not yet recruiting
Manchester, United Kingdom
Contact: Nizar Yonan         
Principal Investigator: Nizar Yonan         
John Radcliffe Hospital Not yet recruiting
Manchester, United Kingdom
Contact: Mario Petrou         
Principal Investigator: Mario Petrou         
Manchester Royal Infirmary Recruiting
Manchester, United Kingdom
Contact: Daniel Keenan         
Principal Investigator: Daniel Keenan         
Freeman Hospital Not yet recruiting
Newcastle, United Kingdom
Contact: John Dark         
Principal Investigator: John Dark         
Trent Cardiac Centre Not yet recruiting
Nottingham, United Kingdom
Contact: David Richens         
Principal Investigator: David Richens         
Derriford Hospital Recruiting
Plymouth, United Kingdom
Contact: Jonathan Unsworth-White         
Principal Investigator: Jonathan Unsworth-White         
Northern General Hospital Not yet recruiting
Sheffield, United Kingdom
Contact: Norman Briffa         
Principal Investigator: Norman Briffa         
Southampton General Hospital Not yet recruiting
Southampton, United Kingdom
Contact: Sunil Ohri         
Principal Investigator: Sunil Ohri         
Swansea Hospital Not yet recruiting
Swansea, United Kingdom
Contact: Aprim Youhana         
Principal Investigator: Aprim Youhana         
Wolverhampton Hospital Not yet recruiting
Wolverhampton, United Kingdom
Contact: Moninder Bhabra         
Principal Investigator: Moninder Bhabra         
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: January 9, 2012
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 October 21, 2014