Effect of Remote Ischaemic Preconditioning on Clinical Outcomes in CABG Surgery
- Conditions
- Coronary Heart Disease
- Interventions
- Procedure: ControlProcedure: Remote ischaemic preconditioning
- Registration Number
- NCT01247545
- Lead Sponsor
- University College, London
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1612
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Control 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. Remote ischaemic conditioning 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.
- Primary Outcome Measures
Name Time Method Major adverse cardiac and cerebral events One year post-surgery Combined endpoint of Cardiovascular death, MI, Revascularisation and Stroke.
- Secondary Outcome Measures
Name Time Method Length of ITU stay ITU stay Peri-operative myocardial injury 72 hours peri-operative period 72 hours area under curve serum troponin-T
LV ejection fraction At one year Echo determined LV ejection fraction
6 minute Walk Test 6 weeks and 12 months post surgery Acute kidney injury Peri-operative Acute kidney injury score and 24 hour area under curve serum NGAL
30 day MACCE 30 days post surgery Major adverse cardiac and cerebral events 30 days post surgery
Length of hospital stay Until hospital discharge Inotrope score 72 hours post surgery Inotrope score after 72 hours
All cause death 1 year post surgery Quality of Life 6 weeks, 3/6/9 and 12 months post surgery Quality of Life assessed using the EQ-5D measurement
Trial Locations
- Locations (28)
Royal Sussex County Hospital
🇬🇧Brighton, Sussex, United Kingdom
Papworth Hospital
🇬🇧Cambridge, United Kingdom
Blackpool Victoria Hospital
🇬🇧Blackpool, United Kingdom
Cardiff & Vale University Health Board
🇬🇧Cardiff, United Kingdom
Edinburgh Royal Infirmary
🇬🇧Edinburgh, United Kingdom
Golden Jubilee Hospital
🇬🇧Glasgow, United Kingdom
Hammersmith Hospital
🇬🇧London, United Kingdom
Harefield Hospital
🇬🇧Harefield, United Kingdom
Glenfield Hospital
🇬🇧Leicester, United Kingdom
Kings College London Hospital
🇬🇧London, United Kingdom
London Chest Hospital
🇬🇧London, United Kingdom
St George's Hospital
🇬🇧London, United Kingdom
St Thomas Hospital
🇬🇧London, United Kingdom
John Radcliffe Hospital
🇬🇧Manchester, United Kingdom
UCLH Heart Hospital
🇬🇧London, United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
Freeman Hospital
🇬🇧Newcastle, United Kingdom
Northern General Hospital
🇬🇧Sheffield, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Trent Cardiac Centre
🇬🇧Nottingham, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom
Swansea Hospital
🇬🇧Swansea, United Kingdom
Wolverhampton Hospital
🇬🇧Wolverhampton, United Kingdom
Essex Cardiothoracic Centre
🇬🇧Basildon, Essex, United Kingdom
St Bartholomew's Hospital
🇬🇧London, United Kingdom
Royal Brompton Hospital
🇬🇧London, United Kingdom
Castle Hill Hospital
🇬🇧Hull, United Kingdom