Coronary artery disease Circulatory System Chronic ischaemic heart disease
Conditions
Interventions
All patients will receive saphenous vein grafts as part of their CABG procedure but the study will investigate the effects of different vein preparation techniques. The study is designed factorially w
Sponsors
University Hospitals Bristol NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 08/11/2010: Male and female patients (aged 18 years and older) undergoing first time elective (standard or urgent priority) coronary artery bypass graft (CABG) at the Bristol Royal Infirmary having one or more saphenous vein grafts will be invited to take part in the study. Initial information at time of registration: Male and female patients (aged 18 years and older) undergoing first time elective (standard or urgent priority) coronary artery bypass graft (CABG) at the Bristol Royal Infirmary having one or more vein grafts will be invited to take part in the study.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 30/08/2012: 1. Need for emergency CABG 2. Need for an additional procedure such as valve replacement 3. Ejection fraction less than 30% 4. Congestive cardiac failure 5. Peripheral vascular disease affecting the leg(s) 6. Pre-operative serum creatinine greater than 104 µmol/l 7. Allergy to iodinated contrast media 8. Unwillingness to participate in follow-up 9. Aged less than 18 years 10. Previous cardiac surgery Previous exclusion criteria between 08/11/2010 and 30/08/2012: 6. Pre-operative serum creatinine greater than 120 µmol/l Initial information at time of registration: 1. Need for emergency CABG 2. Need for an additional procedure such as valve replacement 3. Ejection fraction less than 35% 4. Congestive cardiac failure 5. Peripheral vascular disease 6. Pre-operative serum creatinine greater than 120 µmol/l 7. Allergy to iodinated contrast media 8. Unwillingness to participate in follow-up 9. Aged less than 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wall thickness and lumen size measured with intravascular ultrasound (IVUS) at 12 months post-operatively, adjusting for baseline differences in wall thickness assessed by the histological analysis of harvested vein grafts at operation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Difference in lumen size and graft patency by quantitative angiography, between groups at 12 months post-operatively, adjusting for baseline differences in lumen size and wall thickness assessed by the histological analysis of harvested vein grafts at operation 2. Serious Adverse Events 3. Wound infection (ASEPSIS Score) 4. Length of stay 5. Neuropathic Pain Symptom Inventory (NPSI) leg wound pain or dysaesthesia at 3 and 12 months follow-up 6. Readmission rate within 12 months | — |
Countries
United Kingdom
Outcome results
None listed