Coronary heart disease Circulatory System Chronic ischaemic heart disease
Conditions
Interventions
This study is an international, multicentre open randomised controlled trial, across 40 centres: 20 in the UK and 20 overseas. Trial patients will be randomised to:
1. CABG without cardiopulmonary byp
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current information as of 05/03/2010: Patients having isolated CABG surgery will be eligible if they satisfy the following criteria: 1. Euroscore =5 2. Non-emergency surgery 3. Operation to be carried out via a median sternotomy 4. Written informed patient consent Initial information at time of registration: Patients having isolated CABG surgery will be eligible if they satisfy the following criteria: 1. Patients (male or female) aged greater than or equal to 70 years 2. Male patients under 70 years of age with moderate or poor left ventricular function (ejection fraction less than 50%) 3. Euroscore greater than or equal to 5 4. Non-emergency surgery 5. Operation to be carried out via a median sternotomy 6. Written informed patient consent
Exclusion criteria
Exclusion criteria: Current information as of 05/03/2010: 1. Euroscore <5 2. Emergency operation (immediate revascularisation for haemodynamic instability) 3. Concomitant cardiac procedure with CABG 4. Operation to be carried out via an incision other than a median sternotomy (e.g. anterolateral left thoracotomy) 5. Known contraindication to ONCABG or OPCABG (e.g. calcified aorta, calcified coronaries, small target vessels) Initial information at time of registration: 1. Male patient under 70 years of age with good left ventricular function (ejection fraction greater than 50%) 2. Euroscore less than 5 3. Emergency operation (immediate revascularisation for haemodynamic instability) 4. Concomitant cardiac procedure with CABG 5. Operation to be carried out via an incision other than a median sternotomy (e.g. anterolateral left thoracotomy) 6. Contraindication to ONCABG or OPCABG (e.g. calcified aorta, intramuscular left anterior descending [LAD], calcified coronaries, small target vessels)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is a composite endpoint of death or serious morbidity (CRISPS). This is made up of the following: 1. Death after cardiac surgery within 30 days of the operation from any cause 2. New onset renal failure requiring renal replacement therapy up to and including 30 days of the operation 3. Myocardial infarction up to and including 30 days of the operation 4. Stroke up to and including 30 days of the operation 5. Prolonged ventilation greater than or equal to 96 hours during the index hospital admission 6. Sternal wound dehiscence requiring non-pharmacological intervention up to and including 30 days of the operation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration of intensive care stay 2. Duration of hospital stay 3. Survival, free from death or serious morbidity at one year 4. Resource use (hospital and other healthcare resources) during one year 5. Quality of life at one year: Rose Angina Questionnaire (short), EuroQol EQ-5D, the Coronary Revascularisation Outcome Questionnaire (CROQ; UK patients only) 6. Cost-effectiveness Data will be collected on events between discharge and 30 days at a routine follow-up appointment 4 - 8 weeks after discharge. Questionnaires will be completed by the patient before surgery, at the 4 - 8 week follow-up appointment, and will be posted to patients for completion at 1 year post-surgery. | — |
Countries
United Kingdom
Outcome results
None listed