Study Protocol and short term follow up
| Study period | Schedule of events | ||||||
| Preoperative screening | Intraoperative CABG surgery | Postoperative | Follow-up* | Early discontinuation visit | |||
| Study day\procedure | −10 Days | Day 1 | Day 2 | Days 3 to discharge | Weeks 4–6 | Month 3 (±1 week) | |
| Obtain informed consent† | X | ||||||
| Review inclusion and exclusion criteria | X | ||||||
| Medical history | X | ||||||
| Demographics | X | ||||||
| Prior medications | X | ||||||
| Concomitant medications | X | X | X | X | X | X | |
| 12-lead ECG | X | X | X | ||||
| Randomisation‡ | X | ||||||
| Operative study procedures | X | ||||||
| ICU admission | X | ||||||
| Measure chest tube blood loss | X | X | |||||
| Cardiac assessments§ CKMB¶ | X | X | |||||
| Troponin | X | ||||||
| Glomerular filtration rate (GFR) | X | X | X | X | |||
| Vascular flow measurement** | X | ||||||
| AEs | X | X | X | X | X | X | |
| MDCT angiography | X | X | X | ||||
*Follow-up at the weeks 4–6 and month 3 (+1 week) visit must be clinic visits.
†Inform consent must be obtained before any study-related procedures are conducted.
‡Randomisation will occur prior to saphenous vein is harvesting.
§Routine cardiac laboratory testing to be performed as per standard practice. CKMB, and troponin, laboratory results will be collected for the study patients. eGFR will be done.
¶CKMB testing at 8 hours (cay 1), 24 hours (day 2) and 48 hours (day 3) will be documented.
**Vascular conduit flow will be measured and recorded after reperfusion, prior to chest closure.
AE, adverse Events; CABG, coronary artery bypass grafting; CKMB, creatine kinase kinase myocardial bound; GFR, glomerular filtration rate; ICU, intensive care unit; MDCT, multidetector CT.