Coronary Artery DiseaseMiECSNCT05487612
MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)
A study testing Minimal Invasive Extracorporeal Circulation and Conventional cardiopulmonary bypass in people with Coronary Artery Disease and Aortic Valve Stenosis, run by Aristotle University Of Thessaloniki at 13 sites in 6 countries.
Trial summary
MiECS is one of the largest multicentre randomised controlled trials on extracorporeal circulation conducted under the auspices of Minimal Invasive Extracorporeal Technologies International Society (MiECTiS). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease, Aortic Valve Stenosis, Extracorporeal Circulation; Complications
- What is being tested?
- Minimal Invasive Extracorporeal Circulation and Conventional cardiopulmonary bypass
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 13 sitesin 6 countries
- Study dates
- 26 May 2022to 31 Mar 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing any elective or urgent coronary artery bypass grafting (CABG), aortic valve replacement (AVR) or CABG+AVR surgery using extracorporeal circulation without circulatory arrest.
Who cannot join
- Requirement for emergency or salvage operation.
- Requirement for major aortic surgery (e.g. aortic root replacement).
- Contraindication or objection (e.g. Jehovah's Witnesses) to transfusion of blood products.
- Congenital or acquired platelet, red cell or clotting disorders (patients with iron deficient anaemia will not be excluded).
- Inability to give informed consent for the study (e.g. learning or language difficulties).
Trial locations and contacts
13 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 6 countries
Germany3 sites
- Active, not recruiting
Department of Cardiac Surgery
Coswig, 06869
- Active, not recruiting
Department of Thoracic and Cardiovascular Surgery, University Medical Centre Goettingen
Göttingen
- Completed
Department of Cardiothoracic and Vascular Surgery, Ulm University Hospital
Ulm, 89081
Turkey (Türkiye)3 sites, 2 recruiting
- Active, not recruiting
Department of Cardiovascular Surgery, Ankara City Hospital
Ankara
- Recruiting
Department of Cardiovascular Surgery, Izmir Bakırçay University, Faculty of Medicine
Izmir
Ahmet Daylan, Ass. Prof., ahmet.daylan@icloud.com
Sahin Bozok, Prof., sahinboz@yahoo.com
- Recruiting
Department of Cardiovascular Surgery, Faculty of Medicine, Recep Tayyip Erdoğan University
Rize
Doğuş Hemşinli, Associate Professor, +90 507 233 43 14, dogus.hemsinli@erdogan.edu.tr
Doğuş Hemşinli, Associate Professor
United Kingdom3 sites
- Active, not recruiting
Department of Cardiac Surgery, Royal Papworth Hospital
Cambridge, CB2 0AY
- Active, not recruiting
Deparment of Cardiac Surgery, Castle Hill Hospital
Hull, HU16 5JQ
- Active, not recruiting
Department of Cardiothoracic Surgery, Hammersmith Hospital
London, W120HS
Italy2 sites, 1 recruiting
- Recruiting
Department of Cardiac Surgery GVM Anthea Hospital
Bari, 70124
Giuseppe Nasso, MD, +39 347 8159 178, gnasso@gvmnet.it
- Active, not recruiting
Department of Cardiac Surgery GVM Maria Eleonora Hospital
Palermo, 90135
Canada1 site, 1 recruiting
- Recruiting
Perfusion Services University Health Network, Toronto General Hospital
Toronto, M5G 2C4
Vivek Rao, Vivek.Rao@uhn.ca
Mousumi Mahanta, 416-340-4800 ext. 5275, mailto:mousumi.mahanta@uhn.ca
Greece1 site, 1 recruiting
- Recruiting
Cardiothoracic Department AHEPA University Hospital
Thessaloniki, 54636
Polychronis Antonitsis, Assoc. Prof., +30 2310994871, antonits@auth.gr
About this study
Official title: Minimally Invasive Extracorporeal Circulation Versus Conventional Cardiopulmonary Bypass in Patients Undergoing Cardiac Surgery (MiECS): a Randomised Controlled Trial
MiECS is one of the largest multicentre randomised controlled trials on extracorporeal circulation conducted under the auspices of Minimal Invasive Extracorporeal Technologies International Society (MiECTiS). It is designed to ultimately address the emerging effectiveness of MiECC systems in the light of modern perfusion practice worldwide. The primary hypothesis is that MiECC, as compared to conventional CPB (cCPB), reduces the proportion of patients experiencing serious perfusion-related postoperative morbidity after cardiac surgery. The study will be led by the Clinical Research Unit of the Special Unit for Biomedical Research and Education (SUBRE), Aristotle University of Thessaloniki School of Medicine in Greece (AUSoM) with Chief Investigator Professor Kyriakos Anastasiadis, who is a key-opinion-leader in the field of MiECC, founder and Executive Board of MiECTiS.
Read the detailed description
Despite a fall in mortality rates over the past decade, patients having cardiac surgery continue to experience serious postoperative complications. The risk of serious and relatively common surgical complications is often a consequence of stopping the heart during the operation, using the heart and lung machine (conventional cardiopulmonary bypass; cCPB), and restarting and reperfusing the heart at the end of the operation. Although several strategies have been developed to reduce such complications, they still occur and can be life threatening; they also increase the length of time a patient spends in the hospital.
Miniaturised heart lung machines (minimally invasive extracorporeal circulation; MiECC) have been developed with the aim of reducing the number of postoperative complications arising from using cCPB. Because of the variety of miniaturised systems that have been evaluated, the different types of patients and outcomes investigated, and the poor quality of previous studies, the effectiveness of MiECC in reducing postoperative complications has not been established and most hospitals continue to use cCPB.
Our primary hypothesis is that, compared to cCPB, using a MiECC system during cardiac surgery reduces the proportion of patients having one of several serious postoperative complications (death, myocardial infarction, stroke, acute kidney injury, reintubation, tracheostomy, mechanical ventilation for more than 48 hours, or reoperation) up to 30 days after surgery. In addition, the investigators hypothesise that MiECC reduces the amount of blood products transfused, time to discharge from the cardiac intensive care unit and hospital and the health care resources used during the hospital stay.
Study investigators propose to carry out a large, multicentre randomised controlled trial in 10 to 15 cardiac surgery centres worldwide. Patients will be eligible if they are having coronary artery bypass surgery, aortic valve replace or both using a heart lung machine without circulatory arrest. Centres may recruit patients having all, or a subset of, operation types.
It is expected that 20 % to 23% of patients will experience one or more of the serious complications (the primary outcome). In order to be able confidently to detect a 30% relative reduction in the risk of this outcome, the investigators plan to recruit 1,300 participants across all sites.
- Being tested
- Minimal Invasive Extracorporeal Circulation, Conventional cardiopulmonary bypass
- Keywords
- Cardiopulmonary bypass, Extracorporeal circulation, Minimal invasive extracorporeal circulation, Coronary artery bypass grafting, Aortic valve replacement
- Medical subject headings
- Coronary Artery Disease, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal Invasive Extracorporeal CirculationDevice
Cardiac surgery with Minimal Invasive Extracorporeal Circulation (MiECC).
Conventional cardiopulmonary bypassDevice
Cardiac surgery with conventional cardiopulmonary bypass (cCPB).
| Study group | Role | What they receive |
|---|---|---|
| Minimal Invasive Extracorporeal Circulation (MiECC) | Active comparator | Patients undergoing coronary artery bypass grafting (CABG), aortic valve replacement (AVR), or combined procedure (AVR+CABG) with Minimal Invasive Extracorporeal Circulation (MiECC). Receives: Device: Minimal Invasive Extracorporeal Circulation |
| Conventional Cardiopulmonary Bypass (cCPB) | Active comparator | Patients undergoing coronary artery bypass grafting (CABG), aortic valve replacement (AVR), or combined procedure (AVR+CABG) with conventional cardiopulmonary bypass (cCPB) Receives: Device: Conventional cardiopulmonary bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome of postoperative serious adverse events
Incidence of: death, postoperative myocardial infarction according to Fourth Universal Definition of myocardial infarction, stroke, all stage acute kidney injury, as defined with AKI Network criteria, Re-intubation, need for mechanical ventilation for > 48 hours, including multiple episodes when separated by more than 12 hours, reoperation and septicaemia confirmed by positive blood culture.
Measured: 30 days after randomization following the index admission
Secondary outcomes (13)
All-cause mortality
All-cause mortality
Measured: 30 days after randomization following the index admission
New-onset postoperative atrial fibrillation
Incidence of new-onset postoperative atrial fibrillation
Measured: Through initial hospital admission from surgery to initial discharge from hospital, an average of 1 week.
Rate of red blood cells transfusion
Units of red blood cells transfused
Measured: 30 days after randomization following the index admission
Rate of platelet transfusion
Units of platelets transfused
Measured: 30 days after randomization following the index admission
Rate of fresh frozen plasma transfusion
Units of fresh frozen plasma transfused
Measured: 30 days after randomization following the index admission
Rate of cryoprecipitate transfusion
Units of cryoprecipitate transfused
Measured: 30 days after randomization following the index admission
Activated Factor VII administration
Incidence of activated factor VII administration
Measured: 30 days after randomization following the index admission
Fibrinogen administration
Incidence of fibrinogen administration
Measured: 30 days after randomization following the index admission
Prothrombin complex concentrate administration
Incidence of prothrombin complex concentrate administration
Measured: 30 days after randomization following the index admission
Time to discharge from cardiac ICU
Time to discharge from cardiac ICU
Measured: Through initial hospital admission from surgery to initial discharge from hospital, an average of 1 week.
Time to discharge from hospital
Time to discharge from hospital
Measured: Through initial hospital admission from surgery to initial discharge from hospital, an average of 1 week.
Delirium
Incidence of postoperative delirium
Measured: Up to 5 days postoperatively
Health-Related Quality of Life (HRQoL)
HRQoL assessed with EQ-5D questionnaire
Measured: 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start26 May 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients undergoing elective or urgent coronary artery bypass grafting, aortic valve replacement or both procedures CABG+AVR using extracorporeal circulation without circulatory arrest will be randomised (1:1 ratio) to having surgery using Minimal Invasive Extracorporeal Circulation (MiECC) or conventional cardiopulmonary bypass (cCPB).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- Minimal Invasive Extracorporeal Technologies International Society (MiECTiS)
- Responsible party
- Sponsor
- Investigators
- Kyriakos Anastasiadis, Professor, Study chair, Aristotle University Of ThessalonikiPolychronis Antonitsis, Assoc. Prof., Study director, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487612
- Sponsor's protocol ID
- MiECS
- Acronym
- MiECS
- Status last verified
- Mar 2026
- First submitted
- 1 Aug 2022
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anastasiadis K, Murkin J, Antonitsis P, Bauer A, Ranucci M, Gygax E, Schaarschmidt J, Fromes Y, Philipp A, Eberle B, Punjabi P, Argiriadou H, Kadner A, Jenni H, Albrecht G, van Boven W, Liebold A, de Somer F, Hausmann H, Deliopoulos A, El-Essawi A, Mazzei V, Biancari F, Fernandez A, Weerwind P, Puehler T, Serrick C, Waanders F, Gunaydin S, Ohri S, Gummert J, Angelini G, Falk V, Carrel T. Use of minimal invasive extracorporeal circulation in cardiac surgery: principles, definitions and potential benefits. A position paper from the Minimal invasive Extra-Corporeal Technologies international Society (MiECTiS). Interact Cardiovasc Thorac Surg. 2016 May;22(5):647-62. doi: 10.1093/icvts/ivv380. Epub 2016 Jan 26.
PubMed 26819269Anastasiadis K, Antonitsis P, Asteriou C, Deliopoulos A, Argiriadou H. Modular minimally invasive extracorporeal circulation ensures perfusion safety and technical feasibility in cardiac surgery; a systematic review of the literature. Perfusion. 2022 Nov;37(8):852-862. doi: 10.1177/02676591211026514. Epub 2021 Jun 17.
PubMed 34137323COMICS investigators, The COMICS investigators. Conventional versus minimally invasive extracorporeal circulation in patients undergoing cardiac surgery: protocol for a randomised controlled trial (COMICS). Perfusion. 2021 May;36(4):388-394. doi: 10.1177/0267659120946731. Epub 2020 Aug 12.
PubMed 32781894Wahba A, Milojevic M, Boer C, De Somer FMJJ, Gudbjartsson T, van den Goor J, Jones TJ, Lomivorotov V, Merkle F, Ranucci M, Kunst G, Puis L; EACTS/EACTA/EBCP Committee Reviewers. 2019 EACTS/EACTA/EBCP guidelines on cardiopulmonary bypass in adult cardiac surgery. Eur J Cardiothorac Surg. 2020 Feb 1;57(2):210-251. doi: 10.1093/ejcts/ezz267. No abstract available.
PubMed 31576396Ranucci M, Johnson I, Willcox T, Baker RA, Boer C, Baumann A, Justison GA, de Somer F, Exton P, Agarwal S, Parke R, Newland RF, Haumann RG, Buchwald D, Weitzel N, Venkateswaran R, Ambrogi F, Pistuddi V. Goal-directed perfusion to reduce acute kidney injury: A randomized trial. J Thorac Cardiovasc Surg. 2018 Nov;156(5):1918-1927.e2. doi: 10.1016/j.jtcvs.2018.04.045. Epub 2018 Apr 18.
PubMed 29778331Anastasiadis K, Argiriadou H, Deliopoulos A, Antonitsis P. Minimal invasive extracorporeal circulation (MiECC): the state-of-the-art in perfusion. J Thorac Dis. 2019 Jun;11(Suppl 10):S1507-S1514. doi: 10.21037/jtd.2019.01.66. No abstract available.
PubMed 31293801Kowalewski M, Pawliszak W, Raffa GM, Malvindi PG, Kowalkowska ME, Zaborowska K, Kowalewski J, Tarelli G, Taggart DP, Anisimowicz L. Safety and efficacy of miniaturized extracorporeal circulation when compared with off-pump and conventional coronary artery bypass grafting: evidence synthesis from a comprehensive Bayesian-framework network meta-analysis of 134 randomized controlled trials involving 22 778 patients. Eur J Cardiothorac Surg. 2016 May;49(5):1428-40. doi: 10.1093/ejcts/ezv387. Epub 2015 Nov 3.
PubMed 26537755Anastasiadis K, Antonitsis P, Papazisis G, Haidich B, Liebold A, Punjabi P, Gunaydin S, El-Essawi A, Rao V, Serrick C, Condello I, Nasso G, Bozok S, Daylan A, Argiriadou H, Deliopoulos A, Karapanagiotidis G, Ashkanani F, Moorjani N, Cale A, Erdoes G, Bennett M, Starinieri P, Carrel T, Murkin J. Minimally invasive extracorporeal circulation versus conventional cardiopulmonary bypass in patients undergoing cardiac surgery (MiECS): Rationale and design of a multicentre randomised trial. Perfusion. 2025 May;40(4):923-932. doi: 10.1177/02676591241272009. Epub 2024 Aug 1.
PubMed 39089011