Aortic Valve SurgeryMiECC METNCT07516938
Metabolic Profile and Tissue Perfusion in Patients Undergoing Open Heart Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation
A study testing Real-time tissue oximetry monitoring in people with Aortic Valve Surgery and Coronary Artery Bypass Graft (CABG), run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The aim of the present study is to investigate the protective effect of minimal invasive versus the conventional extracorporeal circulation on tissue homeostasis as evidenced by the preservation of tissue metabolism and cerebral perfusion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Valve Surgery, Coronary Artery Bypass Graft (CABG), Cardiac Surgery
- What is being tested?
- Real-time tissue oximetry monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2022to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing undergoing open heart surgery with accepted indications under extracorporeal circulation
Who cannot join
- need for emergency surgery
- surgery on the thoracic aorta
- severe co-morbities causing anemia, immunosuppression etc.
- immunocompromised patients
- inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Greece1 site
Cardiothoracic Department, Artistotle University of Thessaloniki School of Medicine
Thessaloniki
About this study
Official title: Study of Metabolic Profile and Tissue Perfusion in Patients Undergoing Open Heart Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation. Randomized Study
The aim of the present study is to investigate the protective effect of minimal invasive versus the conventional extracorporeal circulation on tissue homeostasis as evidenced by the preservation of tissue metabolism and cerebral perfusion.
Read the detailed description
The aim of the present study is to investigate the protective effect of minimal invasive versus the conventional extracorporeal circulation on tissue homeostasis as evidenced by the preservation of tissue metabolism and cerebral perfusion. Seventy patients undergoing coronary artery bypass grafting, aortic valve replacement or both procedures will be included in the study. Patients will be randomized in two groups: patients operated with the contemporary minimal invasive extracorporeal circulation (study group) versus patients operated with conventional extracorporeal circulation (control group). All patients will be operated according to the same anesthetic and perfusion protocol. During extracorporeal circulation, the following parameters will be recorded:
- real-time tissue metabolism as indicated by oxygen delivery (DO2), oxygen consumption (VO2), oxygen extraction ratio (O2ER), CO2 consumption (VCO2), arterial and mixed venous saturation (SvO2)
- blood lactate levels at defined intervals
- real time cerebral oximetry (rSO2) using near-infrared spectroscopy (NIRS) The protective effect of minimal invasive extracorporeal circulation will be evidenced with comparative analysis of metabolic parameters between the two study groups. Real-time tissue metabolic parameters will be further associated with clinical data collected during hospital stay including postoperative morbidity and mortality, major adverse cardiac events, acute renal failure, re-intubation, need for prolonged mechanical ventilation (> 48 hours), re-operation, postoperative bleeding, need for blood product transfusion, ICU and total hospital stay.
- Being tested
- Real-time tissue oximetry monitoring
- Keywords
- cardiopulmonary bypass, minimal invasive extracorporeal circulation, extracorporeal circulation, tissue oximetry, near-infrared spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time tissue oximetry monitoringDevice
Real-time tissue metabolism as indicated by oxygen delivery (DO2), oxygen consumption (VO2), oxygen extraction ratio (O2ER), CO2 consumption (VCO2), arterial and mixed venous saturation (SvO2)
| Study group | Role | What they receive |
|---|---|---|
| Minimal Invasive Extracorporeal Circulation (MiECC) | Experimental | Patients undergoing cardiac surgery with Minimal Invasive Extracorporeal Circulation Receives: Device: Real-time tissue oximetry monitoring |
| Conventional Cardiopulmonary Bypass (cCPB) | Active comparator | Patients undergoing cardiac surgery with conventional cardiopulmonary bypass Receives: Device: Real-time tissue oximetry monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue hypoperfusion severity
Area under the curve (AUC) where tissue oxygen delivery indexed (DO2i) remains below the critical value of 280 ml/min/m2.
Measured: During surgery, from initiation of cardiopulmonary bypass to weaning of cardiopulmonary bypass
Secondary outcomes (11)
Perfusion ratio derangement
Incidence of patients that experience perfusion ratio (DO2i/VCO2i) < 5 during extracorporeal circulation.
Measured: During surgery from initiation of extracorporeal circulation to weaning of extracorporeal circulation.
Cerebral hypoperfusion
Incidence of patients that experience a reduction in cerebral near-infrared spectroscopy exceeding -20% from baseline during extracorporeal circulation.
Measured: During surgery, from initiation to weaning of extracorporeal circulation
Overall mortality
Death from any cause
Measured: From surgery to 30 days postoperatively
Major adverse cardiac and cerebrovascular events
Composite incidense od postoperative stroke, myocardial infarction and need fr revascularization.
Measured: From surgery to 30 days postoperatively
Renal failure
Incidence of postoperative renal failure
Measured: From surgery to 30 days postoperatively
Re-intubation
Incidence of re-intubation
Measured: From surgery to 30 days postoperatively
Re-operation
Incidence of re-operation
Measured: From surgery to 30 days postoperatively
Postoperative bleeding
Volume of postoperative blood loss
Measured: From surgery to 12 hours postoperatively
Transfusion
Any blood product transfused
Measured: Perioperatively
ICU stay
Length of ICU stay
Measured: From day of surgery to discharge from ICU, assessed up to 4 weeks postoperatively.
Hospital stay
Length of hospital stay
Measured: From day of surgery to discharge from hospital, assessed up to 4 weeks postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start1 Jan 2022
- Primary completion31 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve SurgeryStudies 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
- All eligible patients will be randomized with computer-generated algorithm to receive cardiac surgery with minimal invasive versus conventional extracorporeal circulation.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Polychronis Antonitsis, Aristotle University Of Thessaloniki
- Investigators
- Kyriakos Anastasiadis, MD, PhD, FETCS, Study chair, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516938
- Sponsor's protocol ID
- MiECC MET
- Acronym
- MiECC MET
- Status last verified
- Apr 2026
- First submitted
- 12 Aug 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anastasiadis 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 34137323Anastasiadis K, Antonitsis P, Deliopoulos A, Argiriadou H. Perfusion matters, and it will always matter in cardiac surgery. Perfusion. 2021 Oct;36(7):677-678. doi: 10.1177/02676591211025154. Epub 2021 Jun 19. No abstract available.
PubMed 34148398Angelini GD, Reeves BC, Culliford LA, Maishman R, Rogers CA, Anastasiadis K, Antonitsis P, Argiriadou H, Carrel T, Keller D, Liebold A, Ashkaniani F, El-Essawi A, Breitenbach I, Lloyd C, Bennett M, Cale A, Gunaydin S, Gunertem E, Oueida F, Yassin IM, Serrick C, Murkin JM, Rao V, Moscarelli M, Condello I, Punjabi P, Rajakaruna C, Deliopoulos A, Bone D, Lansdown W, Moorjani N, Dennis S. Conventional versus minimally invasive extra-corporeal circulation in patients undergoing cardiac surgery: A randomized controlled trial (COMICS). Perfusion. 2025 Apr;40(3):730-741. doi: 10.1177/02676591241258054. Epub 2024 Jun 4.
PubMed 38832503Antonitsis P, Argiriadou H, Gkiouliava A, Deliopoulos A, Mimikos S, Gilou S, Sarridou D, Voucharas C, Karapanagiotidis G, Anastasiadis K. The value of cerebral and somatic near-infrared spectroscopy within an integrated tissue perfusion monitoring strategy in cardiac surgery: A prospective pilot study. Perfusion. 2026 Jan;41(1):69-79. doi: 10.1177/02676591251340942. Epub 2025 May 8.
PubMed 40338150
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Metabolic Profile and Tissue Perfusion in Patients Undergoing Open Heart Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation. Randomized Study
- ClinicalTrials.gov ID
- NCT07516938
- Acronym / sponsor ID
- MiECC MET / MiECC MET
- Keywords
- cardiopulmonary bypass, minimal invasive extracorporeal circulation, extracorporeal circulation, tissue oximetry, near-infrared spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to investigate the protective effect of minimal invasive versus the conventional extracorporeal circulation on tissue homeostasis as evidenced by the preservation of tissue metabolism and cerebral perfusion.
Detailed description
The aim of the present study is to investigate the protective effect of minimal invasive versus the conventional extracorporeal circulation on tissue homeostasis as evidenced by the preservation of tissue metabolism and cerebral perfusion. Seventy patients undergoing coronary artery bypass grafting, aortic valve replacement or both procedures will be included in the study. Patients will be randomized in two groups: patients operated with the contemporary minimal invasive extracorporeal circulation (study group) versus patients operated with conventional extracorporeal circulation (control group). All patients will be operated according to the same anesthetic and perfusion protocol. During extracorporeal circulation, the following parameters will be recorded:
- real-time tissue metabolism as indicated by oxygen delivery (DO2), oxygen consumption (VO2), oxygen extraction ratio (O2ER), CO2 consumption (VCO2), arterial and mixed venous saturation (SvO2)
- blood lactate levels at defined intervals
- real time cerebral oximetry (rSO2) using near-infrared spectroscopy (NIRS) The protective effect of minimal invasive extracorporeal circulation will be evidenced with comparative analysis of metabolic parameters between the two study groups. Real-time tissue metabolic parameters will be further associated with clinical data collected during hospital stay including postoperative morbidity and mortality, major adverse cardiac events, acute renal failure, re-intubation, need for prolonged mechanical ventilation (> 48 hours), re-operation, postoperative bleeding, need for blood product transfusion, ICU and total hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All eligible patients will be randomized with computer-generated algorithm to receive cardiac surgery with minimal invasive versus conventional extracorporeal circulation.
| Arm | Type | Receives |
|---|---|---|
| Minimal Invasive Extracorporeal Circulation (MiECC) | Experimental | Device: Real-time tissue oximetry monitoringPatients undergoing cardiac surgery with Minimal Invasive Extracorporeal Circulation |
| Conventional Cardiopulmonary Bypass (cCPB) | Active comparator | Device: Real-time tissue oximetry monitoringPatients undergoing cardiac surgery with conventional cardiopulmonary bypass |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing undergoing open heart surgery with accepted indications under extracorporeal circulation
Key exclusion criteria (5 listed)
- need for emergency surgery
- surgery on the thoracic aorta
- severe co-morbities causing anemia, immunosuppression etc.
- immunocompromised patients
- inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time tissue oximetry monitoringReal-time tissue metabolism as indicated by oxygen delivery (DO2), oxygen consumption (VO2), oxygen extraction ratio (O2ER), CO2 consumption (VCO2), arterial and mixed venous saturation (SvO2) | Device | Conventional Cardiopulmonary Bypass (cCPB), Minimal Invasive Extracorporeal Circulation (MiECC) |
Primary outcome
Tissue hypoperfusion severity
Time frame: During surgery, from initiation of cardiopulmonary bypass to weaning of cardiopulmonary bypass
Area under the curve (AUC) where tissue oxygen delivery indexed (DO2i) remains below the critical value of 280 ml/min/m2.
11 secondary outcomes
Perfusion ratio derangement
Time frame: During surgery from initiation of extracorporeal circulation to weaning of extracorporeal circulation.
Cerebral hypoperfusion
Time frame: During surgery, from initiation to weaning of extracorporeal circulation
Overall mortality
Time frame: From surgery to 30 days postoperatively
Major adverse cardiac and cerebrovascular events
Time frame: From surgery to 30 days postoperatively
Renal failure
Time frame: From surgery to 30 days postoperatively
Re-intubation
Time frame: From surgery to 30 days postoperatively
Re-operation
Time frame: From surgery to 30 days postoperatively
Postoperative bleeding
Time frame: From surgery to 12 hours postoperatively
Transfusion
Time frame: Perioperatively
ICU stay
Time frame: From day of surgery to discharge from ICU, assessed up to 4 weeks postoperatively.
Hospital stay
Time frame: From day of surgery to discharge from hospital, assessed up to 4 weeks postoperatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 34137323Anastasiadis 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.
- Background: PubMed 34148398Anastasiadis K, Antonitsis P, Deliopoulos A, Argiriadou H. Perfusion matters, and it will always matter in cardiac surgery. Perfusion. 2021 Oct;36(7):677-678. doi: 10.1177/02676591211025154. Epub 2021 Jun 19. No abstract available.
- Background: PubMed 38832503Angelini GD, Reeves BC, Culliford LA, Maishman R, Rogers CA, Anastasiadis K, Antonitsis P, Argiriadou H, Carrel T, Keller D, Liebold A, Ashkaniani F, El-Essawi A, Breitenbach I, Lloyd C, Bennett M, Cale A, Gunaydin S, Gunertem E, Oueida F, Yassin IM, Serrick C, Murkin JM, Rao V, Moscarelli M, Condello I, Punjabi P, Rajakaruna C, Deliopoulos A, Bone D, Lansdown W, Moorjani N, Dennis S. Conventional versus minimally invasive extra-corporeal circulation in patients undergoing cardiac surgery: A randomized controlled trial (COMICS). Perfusion. 2025 Apr;40(3):730-741. doi: 10.1177/02676591241258054. Epub 2024 Jun 4.
- Background: PubMed 40338150Antonitsis P, Argiriadou H, Gkiouliava A, Deliopoulos A, Mimikos S, Gilou S, Sarridou D, Voucharas C, Karapanagiotidis G, Anastasiadis K. The value of cerebral and somatic near-infrared spectroscopy within an integrated tissue perfusion monitoring strategy in cardiac surgery: A prospective pilot study. Perfusion. 2026 Jan;41(1):69-79. doi: 10.1177/02676591251340942. Epub 2025 May 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyriakos Anastasiadis, MD, PhD, FETCS study chair
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time tissue oximetry monitoring in people with Aortic Valve Surgery and Coronary Artery Bypass Graft (CABG), run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue hypoperfusion severity (time frame: During surgery, from initiation of cardiopulmonary bypass to weaning of cardiopulmonary bypass). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07516938, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.