Coronary artery and valve disease Circulatory System Coronary artery and valve disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults with multiple vessel coronary disease and any aortic valve disease and/or any mitral valve disease 2. Surgeons willing to carry out operation via either method
Exclusion criteria
Exclusion criteria: 1. Single vessel coronary disease 2. Marked calcific degeneration of the mitral annulus 3. Reoperation 4. Malignancy 5. Debilitating neurological disease 6. Ongoing sepsis or endocarditis 7. Carotid artery stenosis greater than 75% 8. Critical limb ischaemia 9. Emergency operation for unstable angina 10. Salvage procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint of death, postoperative myocardial infarction, arrhythmia, requirement for pacing for more than 12 hours and/or inotropic support for more than 12 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical measures: 1.1. Duration of cardiopulmonary bypass 1.2. Duration of aortic cross clamp 1.3. Low cardiac output (LCO) 1.4. Blood loss 1.5. Transfusion requirement 1.6. Intubation time 1.7. Chest or wound infection 1.8. Any subsystem organ complication 1.9. Intensive Care Unit (ICU) and hospital stay 2. Metabolic stress: metabolites extracted from myocardial biopsies from the apex of the left ventricle will include adenine nucleotides and related compounds as well as amino acids (alanine/glutamate ratio) and lactate 3. Reperfusion injury: serum concentrations of troponin I will be determined prior to surgery, and at 1, 4, 12, 24, 48 and 72 hours post-operatively | — |
Countries
India, United Kingdom