Left main coronary artery disease requiring coronary artery bypass grafting Circulatory System
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older 2. Angiographically significant left main coronary artery disease, defined as left main coronary artery diameter stenosis of 50% or greater by visual assessment 3. Surgical revascularisation recommended by the multidisciplinary Heart Team 4. Scheduled for non-emergent, primary, isolated coronary artery bypass grafting performed with cardiopulmonary bypass 5. Silent ischaemia, stable angina, unstable angina or recent myocardial infarction, provided that CK-MB has returned to the laboratory reference range before randomisation 6. Absence of moderate-to-severe aortic valve regurgitation 7. Ability to provide written informed consent and comply with study procedures and 30-day follow-up
Exclusion criteria
Exclusion criteria: 1. Any concomitant cardiac surgical procedure in addition to coronary artery bypass grafting, including valve or aortic surgery 2. Previous cardiac surgery 3. Emergency coronary artery bypass grafting 4. Planned off-pump coronary artery bypass grafting 5. Dialysis-dependent kidney failure 6. Any clinical condition for which the operating surgeon considered randomisation between the two myocardial protection strategies inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak postoperative high-sensitivity cardiac troponin I concentration measured using the Access hsTnI assay on a UniCel DxI 600 immunoassay analyser and reported in ng/L at 4, 12, 24 or 48 hours after admission to the intensive care unit following coronary artery bypass grafting | — |
Secondary
| Measure | Time frame |
|---|---|
| Serial hs-cTnI concentrations (ng/L), and hs-cTnI area under the concentration-time curve measured using the Access hsTnI assay on a UniCel DxI 600 immunoassay analyser and reported in ng/L at 4, 12, 24 and 48 hours after ICU admission; area under the curve from 4 to 48 hours | — |
Countries
Serbia