Minimal Invasive Extracorporeal Circulation (MiECC) for Coronary Artery Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cardiothoracic Department AHEPA University Hospital, Thessaloníki, Greece
Coronary Artery Disease+2 More
Minimal Invasive Extracorporeal Circulation - Device
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

1 of 3

Other trials for Coronary Artery Disease

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

1 of 3

Other trials for Coronary Artery Disease

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: Device
Conventional Cardiopulmonary Bypass (cCPB)
Device
ActiveComparator Group · 1 Intervention: Conventional cardiopulmonary bypass · Intervention Types: Device

Trial 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

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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