COMICS study launched; centre recruitment is ongoing
CoMICs study, the large, multicentre randomized controlled trial comparing minimal invasive (MiECC) versus conventional extracorporeal circulation (CECC) started recruiting patients. Up to 30 cardiac surgery centres in Europe, Canada, USA and Saudi Arabia 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 3,500 participants.
You can download the study protocol with the CRF at MiECTiS Members’ Page. The central IRB approval from the Lead Coordinating Centre (Professor Gianni Angelini, Bristol Heart Institute, UK) has been obtained. Evaluation process is organised by Bristol and will be performed on an individual centre basis through Skype. 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 Gianni Angelini (firstname.lastname@example.org) and Principal Investigators Professor Kyriakos Anastasiadis, AHEPA University Hospital, Thessaloniki, Greece (email@example.com) and Professor Thierry Carrel, University Hospital Bern, Switzerland (firstname.lastname@example.org).