Effect of Remote Ischaemic Preconditioning on Clinical Outcomes in CABG Surgery (ERICCA)
This study is currently recruiting participants.
Verified January 2012 by University College, London
Sponsor:
University College, London
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
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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:
- 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
Exclusion Criteria:
- 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)
- 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
Contacts and Locations
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 | |
| St George's Hospital | Not yet recruiting |
| London, United Kingdom | |
| Contact: Marhan Jahangiri, FRCS | |
| Principal Investigator: Marhan Jahangiri, FRCS | |
| London Chest Hospital | Not yet recruiting |
| London, United Kingdom | |
| Contact: Rakesh Uppal, FRCS | |
| Principal Investigator: Rakesh Uppal, FRCS | |
| St Thomas Hospital | Recruiting |
| London, United Kingdom | |
| Principal Investigator: Christopher Blauth, FRCS | |
| Hammersmith Hospital | Recruiting |
| London, United Kingdom | |
| Contact: Prakash Punjabi, FRCS | |
| Principal Investigator: Prakash Punjabi, FRCS | |
| St Bartholomew's Hospital | Not yet recruiting |
| London, United Kingdom | |
| Contact: Rakesh Uppal, FRCS | |
| Principal Investigator: Rakesh Uppal, FRCS | |
| Royal Brompton Hospital | Recruiting |
| London, United Kingdom | |
| Contact: John Pepper, FRCS | |
| Principal Investigator: John Pepper, 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 | |
| Kings College London Hospital | Recruiting |
| London, United Kingdom | |
| Contact: Jatin Desai, FRCS | |
| Principal Investigator: Jatin Desai, FRCS | |
| Manchester Royal Infirmary | Recruiting |
| Manchester, United Kingdom | |
| Contact: Daniel Keenan | |
| Principal Investigator: Daniel Keenan | |
| John Radcliffe Hospital | Not yet recruiting |
| Manchester, United Kingdom | |
| Contact: Mario Petrou | |
| Principal Investigator: Mario Petrou | |
| Wythenshawe Hospital | Not yet recruiting |
| Manchester, United Kingdom | |
| Contact: Nizar Yonan | |
| Principal Investigator: Nizar Yonan | |
| 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 Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013