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Extracorporeal Circulation System
MiECC vs Conventional Bypass for Heart Surgery (MiECS Trial)
N/A
Recruiting
Research Sponsored by Aristotle University Of Thessaloniki
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after randomization following the index admission
Awards & highlights
MiECS Trial Summary
This trial is designed to study whether or not MiECC, as compared to conventional CPB, reduces the proportion of patients experiencing serious perfusion-related postoperative morbidity after cardiac surgery.
Who is the study for?
This trial is for patients needing elective or urgent heart surgery for coronary artery disease or aortic valve issues, using a heart-lung machine but not requiring complex aortic surgery. Participants must be able to consent and can't have blood disorders or objections to blood transfusions.Check my eligibility
What is being tested?
The study compares two types of heart-lung machine techniques: the standard method (conventional cardiopulmonary bypass) and a newer, less invasive system (MiECC). The goal is to see if MiECC reduces serious complications after surgery.See study design
What are the potential side effects?
While specific side effects are not listed, potential risks may include those typically associated with heart-lung machines such as inflammation, bleeding, infection risk, organ dysfunction, and reactions related to surgical intervention.
MiECS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for heart surgery involving bypass or valve replacement without stopping my circulation.
MiECS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days after randomization following the index admission
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after randomization following the index admission
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite outcome of postoperative serious adverse events
Secondary outcome measures
Activated Factor VII administration
Perinatal death
Delirium
+10 moreMiECS Trial Design
2Treatment groups
Active Control
Group I: Minimal Invasive Extracorporeal Circulation (MiECC)Active Control1 Intervention
Patients undergoing coronary artery bypass grafting (CABG), aortic valve replacement (AVR), or combined procedure (AVR+CABG) with Minimal Invasive Extracorporeal Circulation (MiECC).
Group II: Conventional Cardiopulmonary Bypass (cCPB)Active Control1 Intervention
Patients undergoing coronary artery bypass grafting (CABG), aortic valve replacement (AVR), or combined procedure (AVR+CABG) with conventional cardiopulmonary bypass (cCPB)
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Who is running the clinical trial?
Clinical Research Unit, School of Medicine, Aristotle University of ThessalonikiUNKNOWN
Aristotle University Of ThessalonikiLead Sponsor
258 Previous Clinical Trials
75,197 Total Patients Enrolled
1 Trials studying Aortic Valve Stenosis
60 Patients Enrolled for Aortic Valve Stenosis
Kyriakos Anastasiadis, ProfessorStudy ChairAristotle University Of Thessaloniki, School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for heart surgery involving bypass or valve replacement without stopping my circulation.You cannot or do not want to receive blood transfusions, for example, if you are a Jehovah's Witness.I need major surgery on my aorta.I need an urgent or rescue surgery.I do not have any inherited or developed blood disorders, except for iron deficiency anemia.
Research Study Groups:
This trial has the following groups:- Group 1: Minimal Invasive Extracorporeal Circulation (MiECC)
- Group 2: Conventional Cardiopulmonary Bypass (cCPB)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any slots available for enrollment in this medical experiment?
"The research initiative, first posted on May 26th 2022 and recently updated on August 4th of the same year, is currently attempting to enrol participants. This information can be found at clinicaltrials.gov"
Answered by AI
Does this research permit septuagenarians to partake?
"Persons of 18 years or older and below 85 are eligible for enrolment in this clinical trial."
Answered by AI
Who is eligible to take part in this medical research?
"This medical study is seeking 1300 individuals, aged 18 to 85 years old, with coronary artery disease. Furthermore, any potential participants must have undergone elective or urgent CABG (coronary atery bypass grafting), AVR (aortic valve replacement) or CABG+AVR surgery without circulatory arrest via extracorporeal circulation."
Answered by AI
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