At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Minimal Invasive Extracorporeal Circulation (device), Conventional cardiopulmonary bypass (device)
- How long the study runs
- Study runs about 82 months (dates as stated)
- About the drug or intervention
- Minimal Invasive Extracorporeal Circulation — device: Cardiac surgery with Minimal Invasive Extracorporeal Circulation (MiECC). · Conventional cardiopulmonary bypass — device: Cardiac surgery with conventional cardiopulmonary bypass (cCPB).
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by the Aristotle University of Thessaloniki, is comparing two heart surgery techniques: one called MiECC (a minimally invasive heart-lung machine) and the usual, conventional heart-lung machine (cardiopulmonary bypass). It involves people having heart bypass surgery (coronary artery bypass grafting, or CABG), aortic valve replacement (AVR), or both.
Who can take part
- Adults having planned or urgent heart bypass surgery (CABG), aortic valve replacement (AVR), or both, using a heart-lung machine without stopping the circulation.
Who may not be able to
- People needing emergency or 'salvage' surgery.
- People needing major surgery on the aorta (the main artery from the heart), such as aortic root replacement.
- People who cannot have blood transfusions, or who object to them (for example, Jehovah's Witnesses).
- People with inherited or acquired blood problems affecting platelets, red blood cells or clotting (people with iron-deficiency anaemia can still take part).
- People unable to give informed consent, for example due to learning or language difficulties.
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 85 Years
- Who
- All
- Number of participants
- 1,300
- Started
- 2022-05-26
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for coronary artery disease
- • NA - 1,300 participants
- • 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)
Who can take part?
- • Ages 18 Years to 85 Years
- • Diagnosed with coronary artery disease
Where?
- • Cambridge - Department of Cardiac Surgery, Royal Papworth Hospital
- • Hull - Deparment of Cardiac Surgery, Castle Hill Hospital
- • London - Department of Cardiothoracic Surgery, Hammersmith Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This 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.
More detail
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.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 85 Years
- Who can join: All genders
What the study is looking for
- ✓All patients undergoing any elective or urgent coronary artery bypass grafting (CABG), aortic valve replacement...
Who cannot take part
- ✗Requirement for emergency or salvage operation.
- ✗Requirement for major aortic surgery (e.g. aortic root replacement).
- ✗safety concern 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...
- ✗Inability to give agreement to take part for the study (e.g. learning or language difficulties).
See the full criteria
Where Is This Study? (3 UK sites)
Department of Cardiac Surgery, Royal Papworth Hospital
Cambridge CB2 0AY, United Kingdom
Deparment of Cardiac Surgery, Castle Hill Hospital
Hull HU16 5JQ, United Kingdom
Department of Cardiothoracic Surgery, Hammersmith Hospital
London W120HS, United Kingdom
How to Get in Touch
Georgios Papazisis, Assoc. Prof.
Sponsor contactCONTACT