Coronary Artery BypassNCT01603589
Comparison of Minimal Versus Conventional Extracorporeal Circulation in Coronary Surgery
A study testing Coronary artery bypass grafting with the use of minimal invasive extracorporeal circulation and Coronary artery bypass grafting under conventional extracorporeal circulation in people with Coronary Artery Bypass, run by AHEPA University Hospital at 1 site in Greece.
Trial summary
The aim of this study is to assess the effect of minimal (MiECC) versus conventional (CECC) extracorporeal circulation on perfusion characteristics and remote end-organ protection (lungs, brain, kidneys, liver, stomach, intestine), after elective coronary bypass grafting (CABG). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Bypass
- What is being tested?
- Coronary artery bypass grafting with the use of minimal invasive extracorporeal circulation and Coronary artery bypass grafting under conventional extracorporeal circulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2009to Dec 2020
- 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
- All patients scheduled for elective coronary artery bypass grafting
Who cannot join
- history of psychiatric disorder
- inability to undergo neuropsychological assessment
- history of transient ischemic attack or stroke
- carotid artery stenosis > 60% assessed by duplex ultrasonography
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research on Remote End-organ Protection, Clinical Outcome and Quality of Life With Implementation of the Novel Minimal Extracorporeal Circulation Circuit in Open Heart Surgery
The aim of this study is to assess the effect of minimal (MiECC) versus conventional (CECC) extracorporeal circulation on perfusion characteristics and remote end-organ protection (lungs, brain, kidneys, liver, stomach, intestine), after elective coronary bypass grafting (CABG).
Read the detailed description
The aim of this study is to investigate whether coronary surgery with minimal Invasive Extracorporeal Circulation (MiECC) offers advantage over conventional CPB (CECC). In order to draw an evidence-based conclusion, the investigators aim to evaluate perfusion characteristics during coronary surgery with MECC and associated remote end-organ function. Improved end-organ protection translates into improved clinical outcome which greatly affects quality of life. This is the first study in the literature adequately powered to analyse organ pathophysiology during surgery with MECC and at the same time correlating common clinical variables with a detailed quality of life evaluation. Superiority of MECC could provide firm evidence towards widespread use of MECC in coronary surgery as standard of care.
- Conditions
- Coronary Artery Bypass
- Being tested
- Coronary artery bypass grafting with the use of minimal invasive extracorporeal circulation, Coronary artery bypass grafting under conventional extracorporeal circulation
- Keywords
- coronary artery disease, coronary artery bypass grafting, cardiopulmonary bypass, minimal extracorporeal circulation
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary artery bypass grafting with the use of minimal invasive extracorporeal circulationProcedure or surgery
We use a prototype AHEPA (modular type IV) circuit comprised of the standard and a standby accessory. Components of the standard circuit include: aortic cannula, three-stage venous cannula, coated tubing, a centrifugal pump, a new-generation membrane oxygenator with integrated arterial filter, a venous air removal device, a soft coated bag and pulmonary artery as well as aortic root vent. In addition, there is a standby hard-shell reservoir in parallel to the venous line, so as to convert the closed system to an open one. The standby component is bridged to the main circuit with an afferent line which is connected just before the VARD sending blood to the hard-shell reservoir and an efferent that re-directs it back to the VARD. A cell-saver device is added to the circuit for collecting shed blood and washing red blood cells for autotransfusion.
Coronary artery bypass grafting under conventional extracorporeal circulationProcedure or surgery
A standard open CPB circuit is used, consisting of uncoated PVC tubing, a hard-shell venous reservoir, a microporous membrane oxygenator (Dideco, Mirandola, Italy) and a roller pump (Stöckert S3, Munich, Germany). The circuit contains a 40 μm arterial line blood filter (Dideco, Mirandola, Italy) and it is primed with 1500 mL of a balanced crystalloid/colloid solution (1000 mL of Ringer's solution, 200 mL of mannitol 20%, and 300 mL of hydroxyethyl starch 6%). Cardiotomy as well as sump sucker are integrated to the circuit.
| Study group | Role | What they receive |
|---|---|---|
| MiECC group | Active comparator | Patients operated for elective coronary artery bypass grafting with the use of minimal invasive extracorporeal circulation (MiECC). Receives: Procedure: Coronary artery bypass grafting with the use of minimal invasive extracorporeal circulation |
| CECC group | Active comparator | Patients operated for elective coronary artery bypass grafting under conventional extracorporeal circulation (CECC). Receives: Procedure: Coronary artery bypass grafting under conventional extracorporeal circulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remote end-organ perfusion and function (brain, lungs, liver, kidneys, stomach, intestine) intraoperatively and postoperatively during hospital stay
Remote end-organ perfusion and function at 30 days follow-up after elective coronary artery bypass grafting with the use of minimal (MiECC) versus conventional (CECC) extracorporeal circulation.
Measured: 30 days
Secondary outcomes (6)
Postoperative major adverse cardiac and cerebrovascular events (MACCE) that comprise: myocardial infarction, low cardiac output syndrome, stroke, renal failure.
Postoperative major adverse cardiac and cerebrovascular events (MACCE) that comprise: myocardial infarction, low cardiac output syndrome, stroke, renal failure at 30 days follow-up after elective coronary artery bypass grafting with the use of minimal (MiECC) versus conventional (CECC) extracorporeal circulation.
Measured: 30 days
Duration of mechanical ventilation
Duration of mechanical ventilation at 30 days follow-up after elective coronary artery bypass grafting with the use of minimal (MiECC) versus conventional (CECC) extracorporeal circulation.
Measured: 30 days
Length of ICU stay
Length of ICU stay at 30 days follow-up after elective coronary artery bypass grafting with the use of minimal (MiECC) versus conventional (CECC) extracorporeal circulation.
Measured: 30 days
Development of new postoperative atrial fibrillation.
Development of new postoperative atrial fibrillation at 30 days follow-up after elective coronary artery bypass grafting with the use of minimal (MiECC) versus conventional (CECC) extracorporeal circulation.
Measured: 30 days
Neurocognitive function
Neurocognitive evaluation with a battery of specialized tests performed by a dedicated and experienced team in clinical psychology. Evaluation will be performed at specific time intervals: preoperatively, at 1-, 3- and 6-month follow-up.
Measured: 6 months postoperatively
Health-related quality of life
Change in quality of life assessed with SF-36 questionnaire after coronary artery bypass grafting with minimal versus conventional extracorporeal circulation.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study startJan 2009
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery BypassStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHEPA University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyriakos Anastasiadis, AHEPA University Hospital
- Investigators
- Kyriakos Anastasiadis, MD, PhD, FETCS, Principal investigator, Cardiothoracic Department, AHEPA University Hospital, Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603589
- Sponsor's protocol ID
- AHEPA_CTS_04
- Status last verified
- Jan 2021
- First submitted
- 21 May 2012
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Anastasiadis K, Antonitsis P, Haidich AB, Argiriadou H, Deliopoulos A, Papakonstantinou C. Use of minimal extracorporeal circulation improves outcome after heart surgery; a systematic review and meta-analysis of randomized controlled trials. Int J Cardiol. 2013 Apr 5;164(2):158-69. doi: 10.1016/j.ijcard.2012.01.020. Epub 2012 Feb 8.
PubMed 22325958Anastasiadis K, Asteriou C, Deliopoulos A, Argiriadou H, Karapanagiotidis G, Antonitsis P, Grosomanidis V, Misias G, Papakonstantinou C. Haematological effects of minimized compared to conventional extracorporeal circulation after coronary revascularization procedures. Perfusion. 2010 Jul;25(4):197-203. doi: 10.1177/0267659110373840. Epub 2010 Jun 1.
PubMed 20515982
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Remote End-organ Protection, Clinical Outcome and Quality of Life With Implementation of the Novel Minimal Extracorporeal Circulation Circuit in Open Heart Surgery
- ClinicalTrials.gov ID
- NCT01603589
- Acronym / sponsor ID
- AHEPA_CTS_04
- Conditions
- Coronary Artery Bypass
- Keywords
- coronary artery disease, coronary artery bypass grafting, cardiopulmonary bypass, minimal extracorporeal circulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- AHEPA University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 22 May 2012 (estimated)
- 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 this study is to assess the effect of minimal (MiECC) versus conventional (CECC) extracorporeal circulation on perfusion characteristics and remote end-organ protection (lungs, brain, kidneys, liver, stomach, intestine), after elective coronary bypass grafting (CABG).
Detailed description
The aim of this study is to investigate whether coronary surgery with minimal Invasive Extracorporeal Circulation (MiECC) offers advantage over conventional CPB (CECC). In order to draw an evidence-based conclusion, the investigators aim to evaluate perfusion characteristics during coronary surgery with MECC and associated remote end-organ function. Improved end-organ protection translates into improved clinical outcome which greatly affects quality of life. This is the first study in the literature adequately powered to analyse organ pathophysiology during surgery with MECC and at the same time correlating common clinical variables with a detailed quality of life evaluation. Superiority of MECC could provide firm evidence towards widespread use of MECC in coronary surgery as standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MiECC group | Active comparator | Procedure: Coronary artery bypass grafting with the use of minimal invasive extracorporeal circulationPatients operated for elective coronary artery bypass grafting with the use of minimal invasive extracorporeal circulation (MiECC). |
| CECC group | Active comparator | Procedure: Coronary artery bypass grafting under conventional extracorporeal circulationPatients operated for elective coronary artery bypass grafting under conventional extracorporeal circulation (CECC). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients scheduled for elective coronary artery bypass grafting
Key exclusion criteria (4 listed)
- history of psychiatric disorder
- inability to undergo neuropsychological assessment
- history of transient ischemic attack or stroke
- carotid artery stenosis > 60% assessed by duplex ultrasonography
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 |
|---|---|---|
| Coronary artery bypass grafting with the use of minimal invasive extracorporeal circulationWe use a prototype AHEPA (modular type IV) circuit comprised of the standard and a standby accessory. Components of the standard circuit include: aortic cannula, three-stage venous cannula, coated tubing, a centrifugal pump, a new-generation membrane oxygenator with integrated arterial filter, a venous air removal device, a soft coated bag and pulmonary artery as well as aortic root vent. In addition, there is a standby hard-shell reservoir in parallel to the venous line, so as to convert the closed system to an open one. The standby component is bridged to the main circuit with an afferent line which is connected just before the VARD sending blood to the hard-shell reservoir and an efferent that re-directs it back to the VARD. A cell-saver device is added to the circuit for collecting shed blood and washing red blood cells for autotransfusion. | Procedure or surgery | MiECC group |
| Coronary artery bypass grafting under conventional extracorporeal circulationA standard open CPB circuit is used, consisting of uncoated PVC tubing, a hard-shell venous reservoir, a microporous membrane oxygenator (Dideco, Mirandola, Italy) and a roller pump (Stöckert S3, Munich, Germany). The circuit contains a 40 μm arterial line blood filter (Dideco, Mirandola, Italy) and it is primed with 1500 mL of a balanced crystalloid/colloid solution (1000 mL of Ringer's solution, 200 mL of mannitol 20%, and 300 mL of hydroxyethyl starch 6%). Cardiotomy as well as sump sucker are integrated to the circuit. | Procedure or surgery | CECC group |
Primary outcome
Remote end-organ perfusion and function (brain, lungs, liver, kidneys, stomach, intestine) intraoperatively and postoperatively during hospital stay
Time frame: 30 days
Remote end-organ perfusion and function at 30 days follow-up after elective coronary artery bypass grafting with the use of minimal (MiECC) versus conventional (CECC) extracorporeal circulation.
6 secondary outcomes
Postoperative major adverse cardiac and cerebrovascular events (MACCE) that comprise: myocardial infarction, low cardiac output syndrome, stroke, renal failure.
Time frame: 30 days
Duration of mechanical ventilation
Time frame: 30 days
Length of ICU stay
Time frame: 30 days
Development of new postoperative atrial fibrillation.
Time frame: 30 days
Neurocognitive function
Time frame: 6 months postoperatively
Health-related quality of life
Time frame: 6 months 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 12 Jan 2021.
- Background: PubMed 22325958Anastasiadis K, Antonitsis P, Haidich AB, Argiriadou H, Deliopoulos A, Papakonstantinou C. Use of minimal extracorporeal circulation improves outcome after heart surgery; a systematic review and meta-analysis of randomized controlled trials. Int J Cardiol. 2013 Apr 5;164(2):158-69. doi: 10.1016/j.ijcard.2012.01.020. Epub 2012 Feb 8.
- Background: PubMed 20515982Anastasiadis K, Asteriou C, Deliopoulos A, Argiriadou H, Karapanagiotidis G, Antonitsis P, Grosomanidis V, Misias G, Papakonstantinou C. Haematological effects of minimized compared to conventional extracorporeal circulation after coronary revascularization procedures. Perfusion. 2010 Jul;25(4):197-203. doi: 10.1177/0267659110373840. Epub 2010 Jun 1.
- CardioThoracic Surgery NetworkLink provided by the sponsor.
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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 principal investigator
Cardiothoracic Department, AHEPA University Hospital, Thessaloniki, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary artery bypass grafting with the use of minimal invasive extracorporeal circulation and Coronary artery bypass grafting under conventional extracorporeal circulation in people with Coronary Artery Bypass, run by AHEPA University Hospital 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 12 Jan 2021. 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?
Remote end-organ perfusion and function (brain, lungs, liver, kidneys, stomach, intestine) intraoperatively and postoperatively during hospital stay (time frame: 30 days). 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 NCT01603589, which also lists 2 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 12 Jan 2021.