Coronary Artery DiseaseNCT05479188
Comparative Analysis of the Microcirculation During Cardiac Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation
A study testing Sublingual microscopy in people with Coronary Artery Disease and Aortic Valve Stenosis, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery with minimal invasive versus conventional extracorporeal circulation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease, Aortic Valve Stenosis, Mitral Disease
- What is being tested?
- Sublingual microscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 1 Dec 2021to 31 Dec 2023
- 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 85 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
- patients undergoing emergency surgery
- patients in preoperative cardiogenic shock with evidence of tissue malperfusion
- patients with severe peripheral vascular disease
- patients unable to give informed consent
Trial locations and contacts
1 site in 1 country.
Greece1 site
Cardiothoracic Department, AHEPA University Hospital
Thessaloniki, 54636
About this study
The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery with minimal invasive versus conventional extracorporeal circulation.
Read the detailed description
Background: Cardiac surgery is performed with the use of extracorporeal circulation which triggers a systemic inflammatory response leading to end-organ dysfunction. Contemporary minimal invasive extracorporeal circulation represents an evolution of the conventional extracorporeal circulation that reduces systemic inflammatory response and improves clinical outcome in large studies. A potential explanation includes preservation of tissue microcirculation with minimal invasive extracorporeal circulation as the underlying pathophysiologic mechanism.
Aim: The aim of the present study is to detect differences in tissue microcirculation during cardiopulmonary bypass with minimal (study group) versus conventional (control group) in patients undergoing open heart surgery.
Study type: This is a randomized comparative study. Patients: The study group consists of sixty patients scheduled for elective open-heart surgery (coronary artery bypass grafting, aortic valve replacement of combined procedure) at the Cardiothoracic Department School of Medicine Aristotle University of Thessaloniki.
Intervention: Patients included in the study will be randomly assigned in two groups with a computer-generated algorithm. Study group will undergo cardiac surgery with minimal invasive extracorporeal circulation while control group will be operated with the use of conventional extracorporeal circulation.
Protocol: In both groups tissue microcirculation will be assessed with the use of a specifically designed second generation hand-held video monitoring device which uses sidestream dark field (SDF) imaging placed at the sublingual mucosa. Microcirculatory assessments will be performed at the following time-points: before induction of anesthesia (baseline - T0), after induction of general anesthesia (T1), after initiation of cardiopulmonary bypass (T2) and immediately after weaning cardiopulmonary bypass (T3).
Outcomes: The composite primary outcome of the study consists of obtained differences in the main microcirculatory quantitative variables (Proportion of Perfused Vessels, Microvascular Flow Index, Total Vascular Density, Perfused Vessel Density) during defined time points. Secondary outcomes consist of differences in postoperative 30-days morbidity and mortality.
- Being tested
- Sublingual microscopy
- Keywords
- extracorporeal circulation, Minimal Invasive Extracorporeal Circulation, cardiopulmonary bypass, cerebral oximetry, microcirculation, near-infrared spectroscopy
- Medical subject headings
- Coronary Artery Disease, Aortic Valve Stenosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual microscopyDevice
Evaluation of microcirculation with sublingual microscopy.
| Study group | Role | What they receive |
|---|---|---|
| Minimal Invasive Extracorporeal Circulation (MiECC) | Active comparator | Patients undergoing cardiac surgery with Minimal Invasive Extracorporeal Circulation. Receives: Device: Sublingual microscopy |
| Conventional cardiopulmonary Bypass (cCPB) | Active comparator | Patients undergoing cardiac surgery with conventional cardiopulmonary bypass. Receives: Device: Sublingual microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of perfused vessels assessed with sublingual microscopy
Proportion of perfused vessels (PPV) assessed with sublingual microscopy.
Measured: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Total vascular density assessed with sublingual microscopy
Total vascular density (TVD) assessed with sublingual microscopy.
Measured: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Perfused vessel density assessed with sublingual microscopy
Perfused vessel density (PVD) assessed with sublingual microscopy.
Measured: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Microvascular Flow Index (MFI)
Microvascular Flow Index (MFI) assessed with sublingual microscopy
Measured: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Secondary outcomes (13)
Peak lactate levels
Peak lactate levels during cardiopulmonary bypass in mmol/l
Measured: During surgery from induction to weaning of cardiopulmonary bypass
Mean arterial pressure
Mean arterial pressure during cardiopulmonary bypass
Measured: During surgery from induction to weaning of cardiopulmonary bypass
Overall mortality rate
Incidence of death from any cause
Measured: From surgery to 30 days postoperatively
Rate of preoperative myocardial infarction
Incidence of perioperative myocardial infarction
Measured: From surgery to 30 days postoperatively
Rate of postoperative stroke
Incidence of patients that experience a postperative stroke verified with CT brain scan
Measured: From surgery to 30 days postoperatively
Rate of postoperative revascularization
Incidence of patients who require postoperative revascularization
Measured: From surgery to 30 days postoperatively
Rate of postoperative renal failure
Incidence of patients that experience postoperative acute kidney injury according too AKIN criteria
Measured: From surgery to 30 days postoperatively
Rate of re-intubation
Incidence of patients that required re-intubation
Measured: From surgery to 30 days postoperatively
Rate of re-operation
Incidence of patients that required a re-operation
Measured: From surgery to 30 days postoperatively
Volume of postoperative bleeding
Volume of postoperative bleeding (ml)
Measured: From ICU admission to 12 hours postoperatively
Rate of blood product transfusion
Incidence of any blood product transfusion
Measured: Postoperatively up to 30 days
Length of ICU stay
Total length of ICU stay in hours
Measured: Perioperatively, up to 4 weeks after surgery
Length of hospital stay
Length of hospital stay in days
Measured: Perioperatively, from the day of operation up to 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Dec 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Diagnosis
- 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyriakos Anastasiadis, Aristotle University Of Thessaloniki
- Investigators
- Kyriakos Anastasiadis, Prof., Study director, Aristotle University Of ThessalonikiHelena Argiriadou, Assoc. Prof., Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479188
- Sponsor's protocol ID
- AUS_CTS
- Status last verified
- Apr 2026
- First submitted
- 22 Jul 2022
- Last updated
- 7 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, Deliopoulos A, Argiriadou H. A multidisciplinary perioperative strategy for attaining "more physiologic" cardiac surgery. Perfusion. 2017 Sep;32(6):446-453. doi: 10.1177/0267659117700488. Epub 2017 Mar 10.
PubMed 28692337Yuruk K, Bezemer R, Euser M, Milstein DM, de Geus HH, Scholten EW, de Mol BA, Ince C. The effects of conventional extracorporeal circulation versus miniaturized extracorporeal circulation on microcirculation during cardiopulmonary bypass-assisted coronary artery bypass graft surgery. Interact Cardiovasc Thorac Surg. 2012 Sep;15(3):364-70. doi: 10.1093/icvts/ivs271. Epub 2012 Jun 14.
PubMed 22700685Donndorf P, Kuhn F, Vollmar B, Rosner J, Liebold A, Gierer P, Steinhoff G, Kaminski A. Comparing microvascular alterations during minimal extracorporeal circulation and conventional cardiopulmonary bypass in coronary artery bypass graft surgery: a prospective, randomized study. J Thorac Cardiovasc Surg. 2012 Sep;144(3):677-83. doi: 10.1016/j.jtcvs.2012.05.037. Epub 2012 Jun 12.
PubMed 22698563Koning NJ, Vonk AB, Meesters MI, Oomens T, Verkaik M, Jansen EK, Baufreton C, Boer C. Microcirculatory perfusion is preserved during off-pump but not on-pump cardiac surgery. J Cardiothorac Vasc Anesth. 2014 Apr;28(2):336-41. doi: 10.1053/j.jvca.2013.05.026. Epub 2013 Oct 23.
PubMed 24161555Kara A, Akin S, Ince C. The response of the microcirculation to cardiac surgery. Curr Opin Anaesthesiol. 2016 Feb;29(1):85-93. doi: 10.1097/ACO.0000000000000280.
PubMed 26658179
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of the Microcirculation During Cardiac Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation
- ClinicalTrials.gov ID
- NCT05479188
- Acronym / sponsor ID
- AUS_CTS
- Keywords
- extracorporeal circulation, Minimal Invasive Extracorporeal Circulation, cardiopulmonary bypass, cerebral oximetry, microcirculation, near-infrared spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 29 Jul 2022 (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 proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery with minimal invasive versus conventional extracorporeal circulation.
Detailed description
Background: Cardiac surgery is performed with the use of extracorporeal circulation which triggers a systemic inflammatory response leading to end-organ dysfunction. Contemporary minimal invasive extracorporeal circulation represents an evolution of the conventional extracorporeal circulation that reduces systemic inflammatory response and improves clinical outcome in large studies. A potential explanation includes preservation of tissue microcirculation with minimal invasive extracorporeal circulation as the underlying pathophysiologic mechanism.
Aim: The aim of the present study is to detect differences in tissue microcirculation during cardiopulmonary bypass with minimal (study group) versus conventional (control group) in patients undergoing open heart surgery.
Study type: This is a randomized comparative study. Patients: The study group consists of sixty patients scheduled for elective open-heart surgery (coronary artery bypass grafting, aortic valve replacement of combined procedure) at the Cardiothoracic Department School of Medicine Aristotle University of Thessaloniki.
Intervention: Patients included in the study will be randomly assigned in two groups with a computer-generated algorithm. Study group will undergo cardiac surgery with minimal invasive extracorporeal circulation while control group will be operated with the use of conventional extracorporeal circulation.
Protocol: In both groups tissue microcirculation will be assessed with the use of a specifically designed second generation hand-held video monitoring device which uses sidestream dark field (SDF) imaging placed at the sublingual mucosa. Microcirculatory assessments will be performed at the following time-points: before induction of anesthesia (baseline - T0), after induction of general anesthesia (T1), after initiation of cardiopulmonary bypass (T2) and immediately after weaning cardiopulmonary bypass (T3).
Outcomes: The composite primary outcome of the study consists of obtained differences in the main microcirculatory quantitative variables (Proportion of Perfused Vessels, Microvascular Flow Index, Total Vascular Density, Perfused Vessel Density) during defined time points. Secondary outcomes consist of differences in postoperative 30-days morbidity and mortality.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- 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) | Active comparator | Device: Sublingual microscopyPatients undergoing cardiac surgery with Minimal Invasive Extracorporeal Circulation. |
| Conventional cardiopulmonary Bypass (cCPB) | Active comparator | Device: Sublingual microscopyPatients undergoing cardiac surgery with conventional cardiopulmonary bypass. |
Who may qualify
- Ages
- 18 to 85 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 (4 listed)
- patients undergoing emergency surgery
- patients in preoperative cardiogenic shock with evidence of tissue malperfusion
- patients with severe peripheral vascular disease
- patients unable 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 |
|---|---|---|
| Sublingual microscopyEvaluation of microcirculation with sublingual microscopy. | Device | Conventional cardiopulmonary Bypass (cCPB), Minimal Invasive Extracorporeal Circulation (MiECC) |
Primary outcome
Proportion of perfused vessels assessed with sublingual microscopy
Time frame: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Proportion of perfused vessels (PPV) assessed with sublingual microscopy.
Total vascular density assessed with sublingual microscopy
Time frame: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Total vascular density (TVD) assessed with sublingual microscopy.
Perfused vessel density assessed with sublingual microscopy
Time frame: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Perfused vessel density (PVD) assessed with sublingual microscopy.
Microvascular Flow Index (MFI)
Time frame: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Microvascular Flow Index (MFI) assessed with sublingual microscopy
13 secondary outcomes
Peak lactate levels
Time frame: During surgery from induction to weaning of cardiopulmonary bypass
Mean arterial pressure
Time frame: During surgery from induction to weaning of cardiopulmonary bypass
Overall mortality rate
Time frame: From surgery to 30 days postoperatively
Rate of preoperative myocardial infarction
Time frame: From surgery to 30 days postoperatively
Rate of postoperative stroke
Time frame: From surgery to 30 days postoperatively
Rate of postoperative revascularization
Time frame: From surgery to 30 days postoperatively
Rate of postoperative renal failure
Time frame: From surgery to 30 days postoperatively
Rate of re-intubation
Time frame: From surgery to 30 days postoperatively
Rate of re-operation
Time frame: From surgery to 30 days postoperatively
Volume of postoperative bleeding
Time frame: From ICU admission to 12 hours postoperatively
Rate of blood product transfusion
Time frame: Postoperatively up to 30 days
Length of ICU stay
Time frame: Perioperatively, up to 4 weeks after surgery
Length of hospital stay
Time frame: Perioperatively, from the day of operation up to 4 weeks after surgery
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 7 Apr 2026.
- Background: PubMed 28692337Anastasiadis K, Antonitsis P, Deliopoulos A, Argiriadou H. A multidisciplinary perioperative strategy for attaining "more physiologic" cardiac surgery. Perfusion. 2017 Sep;32(6):446-453. doi: 10.1177/0267659117700488. Epub 2017 Mar 10.
- Background: PubMed 22700685Yuruk K, Bezemer R, Euser M, Milstein DM, de Geus HH, Scholten EW, de Mol BA, Ince C. The effects of conventional extracorporeal circulation versus miniaturized extracorporeal circulation on microcirculation during cardiopulmonary bypass-assisted coronary artery bypass graft surgery. Interact Cardiovasc Thorac Surg. 2012 Sep;15(3):364-70. doi: 10.1093/icvts/ivs271. Epub 2012 Jun 14.
- Background: PubMed 22698563Donndorf P, Kuhn F, Vollmar B, Rosner J, Liebold A, Gierer P, Steinhoff G, Kaminski A. Comparing microvascular alterations during minimal extracorporeal circulation and conventional cardiopulmonary bypass in coronary artery bypass graft surgery: a prospective, randomized study. J Thorac Cardiovasc Surg. 2012 Sep;144(3):677-83. doi: 10.1016/j.jtcvs.2012.05.037. Epub 2012 Jun 12.
- Background: PubMed 24161555Koning NJ, Vonk AB, Meesters MI, Oomens T, Verkaik M, Jansen EK, Baufreton C, Boer C. Microcirculatory perfusion is preserved during off-pump but not on-pump cardiac surgery. J Cardiothorac Vasc Anesth. 2014 Apr;28(2):336-41. doi: 10.1053/j.jvca.2013.05.026. Epub 2013 Oct 23.
- Background: PubMed 26658179Kara A, Akin S, Ince C. The response of the microcirculation to cardiac surgery. Curr Opin Anaesthesiol. 2016 Feb;29(1):85-93. doi: 10.1097/ACO.0000000000000280.
- 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, Prof. study director
Aristotle University Of Thessaloniki
Helena Argiriadou, Assoc. Prof. principal investigator
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 Sublingual microscopy in people with Coronary Artery Disease and Aortic Valve Stenosis, 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 4 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 7 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?
Proportion of perfused vessels assessed with sublingual microscopy (time frame: During surgery, from induction of anesthesia to weaning of extracorporeal circulation). The study lists 4 primary outcomes in all. 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 NCT05479188, which also lists 5 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 7 Apr 2026.