MiECS study is new large, high quality RCT under the auspices of MiECTiS, that aims to ultimately address the uncertainty about the effectiveness of MiECC in the light of the resurgence in cardiac activity by most cardiac centres worldwide. By incorporating the lessons learned from COMICS, the new study could focus on specific perfusion-related clinical outcomes after cardiac surgery that could be potentially affected by MiECC and should also target for higher-risk patients undergoing complex procedures that are more likely to develop complications and, thus, benefit from the advanced technology. If MiECC is shown to be effective in such a trial, the technology is available and could be rapidly implemented in practice.
Up to 16 cardiac surgery centres in Europe and Canada declared their will to participate. Patients will be eligible if they are having coronary artery bypass surgery, aortic valve replacement or both. Centres may recruit patients having all, or a subset of these types of operations. This is one the largest multicenter trials in the field of Cardiac Surgery. Sample size has been estimated to approximately 1,300 participants.
You can download the study overview here. The central IRB approval from the Lead Coordinating Centre [Special Unit for Biomedical Research and Education (SUBRE), Aristotle University of Thessaloniki (AUTh), School of Medicine] has been obtained. Eligibility criterion for a centre to participate to the study will be the proof of utilizing on-site both technologies (50 cases on MiECC are mandatory as background).
There is still place for centres interested in recruiting patients for the study. Please, contact Chief Investigator Professor Kyriakos Anastasiadis, Aristotle University of Thessaloniki, Greece (anastasi@auth.gr) and study coordinator Assoc. Professor Polychronis Antonitsis, Aristotle University of Thessaloniki, Greece (antonits@auth.gr).