Minimal Invasive Extracorporeal Circulation (MiECC) for Coronary Artery Disease
Phase-Based Progress Estimates
Effectiveness
Safety
Cardiothoracic Department AHEPA University Hospital, Thessaloníki, Greece
Coronary Artery Disease+2 More
Minimal Invasive Extracorporeal Circulation - DeviceEligibility
18+
All Sexes
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Eligibility
18+
All Sexes
What conditions do you have?
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Study 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). 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.
Eligible Conditions
- Extracorporeal Circulation; Complications
- Coronary Artery Disease
- Aortic Valve Stenosis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 17 Secondary · Reporting Duration: 30 days after randomization following the index admission
Day 30
Activated Factor VII administration
All-cause mortality
Composite outcome of postoperative serious adverse events
Cryoprecipitate transfusion
Fibrinogen administration
Fresh frozen plasma transfusion
Platelet transfusion
Prothrombin complex concentrate administration
Rate of cryoprecipitate transfusion
Rate of fresh frozen plasma transfusion
Rate of platelet transfusion
Rate of red blood cells transfusion
Red blood cells transfusion
90 days after randomization
Health-Related Quality of Life (HRQoL)
Week 1
New-onset postoperative atrial fibrillation
Time to discharge from cardiac ICU
Time to discharge from hospital
Day 5
Delirium
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Minimal Invasive Extracorporeal Circulation (MiECC)
1 of 2
Conventional Cardiopulmonary Bypass (cCPB)
1 of 2
Active Control
1300 Total Participants · 2 Treatment Groups
Primary Treatment: Minimal Invasive Extracorporeal Circulation (MiECC) · No Placebo Group · N/A
Minimal Invasive Extracorporeal Circulation (MiECC)
Device
ActiveComparator Group · 1 Intervention: Minimal Invasive Extracorporeal Circulation · Intervention Types: DeviceConventional Cardiopulmonary Bypass (cCPB)
Device
ActiveComparator Group · 1 Intervention: Conventional cardiopulmonary bypass · Intervention Types: DeviceTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days after randomization following the index admission
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Anastasiadis, Kyriakos, Polychronis Antonitsis, Christos Asteriou, Apostolos Deliopoulos, and Helena Argiriadou. 2021. “Modular Minimally Invasive Extracorporeal Circulation Ensures Perfusion Safety and Technical Feasibility in Cardiac Surgery; a Systematic Review of the Literature”. Perfusion. SAGE Publications. doi:10.1177/02676591211026514.
- Anastasiadis, Kyriakos, Helena Argiriadou, Apostolos Deliopoulos, and Polychronis Antonitsis. 2019. “Minimal Invasive Extracorporeal Circulation (miecc): The State-of-the-art in Perfusion”. Journal of Thoracic Disease. AME Publishing Company. doi:10.21037/jtd.2019.01.66.
- Wahba, Alexander, Milan Milojevic, Christa Boer, Filip M J J De Somer, Tomas Gudbjartsson, Jenny van den Goor, Timothy J Jones, et al.. 2019. “2019 EACTS/EACTA/EBCP Guidelines on Cardiopulmonary Bypass in Adult Cardiac Surgery”. European Journal of Cardio-thoracic Surgery. Oxford University Press (OUP). doi:10.1093/ejcts/ezz267.
- Ranucci, Marco, Ian Johnson, Timothy Willcox, Robert A. Baker, Christa Boer, Andreas Baumann, George A. Justison, et al.. 2018. “Goal-directed Perfusion to Reduce Acute Kidney Injury: A Randomized Trial”. The Journal of Thoracic and Cardiovascular Surgery. Elsevier BV. doi:10.1016/j.jtcvs.2018.04.045.
- Kowalewski, Mariusz, Wojciech Pawliszak, Giuseppe Maria Raffa, Pietro Giorgio Malvindi, Magdalena Ewa Kowalkowska, Katarzyna Zaborowska, Janusz Kowalewski, Giuseppe Tarelli, David Paul Taggart, and Lech Anisimowicz. 2015. “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”. European Journal of Cardio-thoracic Surgery. Oxford University Press (OUP). doi:10.1093/ejcts/ezv387.
- Anastasiadis, Kyriakos, John Murkin, Polychronis Antonitsis, Adrian Bauer, Marco Ranucci, Erich Gygax, Jan Schaarschmidt, et al.. 2016. “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)”. Interactive Cardiovascular and Thoracic Surgery. Oxford University Press (OUP). doi:10.1093/icvts/ivv380.
- Angelini, Gianni D, Barnaby C Reeves, Jonathan Evans, Lucy A Culliford, Laura Collett, Chris A Rogers, Elizabeth Stokes, et al.. 2020. “Conventional Versus Minimally Invasive Extracorporeal Circulation in Patients Undergoing Cardiac Surgery: Protocol for a Randomised Controlled Trial (COMICS)”. Perfusion. SAGE Publications. doi:10.1177/0267659120946731.
- 2022. "MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05487612.
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