Complication of Coronary Artery Bypass GraftOPCBAGNCT03609723
Combined Use of a Novel Cardioplegic Formula With MPS ® Using the MiECC in Isolated CABG Versus OPCABG
An observational study of Complication of Coronary Artery Bypass Graft and Complication of Extracorporeal Circulation, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
A patient group receiving a novel cardioplegic formula with MPS ® (Myocardial protection system) and using the MiECC (Minimal extracorporeal circulation system) when undergoing coronary artery bypass grafting is compared to a retrospective patient group undergoing Off-pump coronary artery bypass grafting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complication of Coronary Artery Bypass Graft, Complication of Extracorporeal Circulation
- What is being tested?
- CABG
- Type of treatment
- Surgery or procedure
- How many people
- 2,433 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Jun 2010to 31 Dec 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing coronary artery bypass grafting with application of a myocardial protection system (MPS ®) and using a minimal extracorporeal circulation system (MiECC) Patients undergoing coronary artery bypass grafting without use of a minimal extracorporeal circulation system (Off-pump coronary artery bypass grafting = OPCABG)
Who may be able to join
- CABG using MPS® or OPCABG
Who cannot join
- use of other colloid solution than Cardioplexol ® for MPS®
- other inventions than CABG
- myocardial infarction <7 days before CABG
- patients denial of data use
Trial locations and contacts
1 site in 1 country.
About this study
A patient group receiving a novel cardioplegic formula with MPS ® (Myocardial protection system) and using the MiECC (Minimal extracorporeal circulation system) when undergoing coronary artery bypass grafting is compared to a retrospective patient group undergoing Off-pump coronary artery bypass grafting.
- Being tested
- CABG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CABGProcedure or surgery
CABG with application of a myocardial protection system (MPS ®) and using a minimal extracorporeal circulation system (MiECC) or CABG without use of a minimal extracorporeal circulation system (Off-pump coronary artery bypass grafting = OPCABG)
| Study group | Role | What they receive |
|---|---|---|
| MPS® in patients with CABG | Patients undergoing coronary artery bypass grafting with application of a myocardial protection system (MPS ®) and using a minimal extracorporeal circulation system (MiECC) Receives: Procedure: CABG | |
| OPCABG in patients with CABG | Patients undergoing coronary artery bypass grafting without use of a minimal extracorporeal circulation system (Off-pump coronary artery bypass grafting = OPCABG) Receives: Procedure: CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of cardial biomarkers as high sensitive troponin T (hs-TrT), Creatinkinase (CK) and Creatinkinase myocardial type (CK-MB)
high sensitive troponin T (hs-TrT), Creatinkinase, (CK) Creatinkinase myocardial type (CK-MB)
Measured: perioperative during hospital stay for CABG
Secondary outcomes (3)
mortality
death after coronary artery bypass grafting
Measured: 30 days after CABG
need for intensive care unit
duration of stay at intensive care unit
Measured: perioperative during hospital stay for CABG
occurence of dysrhythmia
rhythm disturbance after CABG
Measured: perioperative during hospital stay for CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start12 Jun 2010
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Coronary Artery Bypass GraftStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,433 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver Reuthebuch, PD MD, Principal investigator, Klinik für Herzchirurgie, Universitätsspital Basel Spitalstrasse 21 4031 Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609723
- Sponsor's protocol ID
- 2018-00923; ch18reuthebuch2
- Other IDs
- 2018
- Acronym
- OPCBAG
- Status last verified
- Jul 2019
- First submitted
- 17 Jul 2018
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Use of a Novel Cardioplegic Formula With MPS ® Using the MiECC in Isolated CABG Versus OPCABG
- ClinicalTrials.gov ID
- NCT03609723
- Acronym / sponsor ID
- OPCBAG / 2018-00923; ch18reuthebuch2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,433 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 12 Jun 2010 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 1 Aug 2018 (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.
A patient group receiving a novel cardioplegic formula with MPS ® (Myocardial protection system) and using the MiECC (Minimal extracorporeal circulation system) when undergoing coronary artery bypass grafting is compared to a retrospective patient group undergoing Off-pump coronary artery bypass grafting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPS® in patients with CABG | – | Procedure: CABGPatients undergoing coronary artery bypass grafting with application of a myocardial protection system (MPS ®) and using a minimal extracorporeal circulation system (MiECC) |
| OPCABG in patients with CABG | – | Procedure: CABGPatients undergoing coronary artery bypass grafting without use of a minimal extracorporeal circulation system (Off-pump coronary artery bypass grafting = OPCABG) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing coronary artery bypass grafting with application of a myocardial protection system (MPS ®) and using a minimal extracorporeal circulation system (MiECC) Patients undergoing coronary artery bypass grafting without use of a minimal extracorporeal circulation system (Off-pump coronary artery bypass grafting = OPCABG)
Key inclusion criteria (1 listed)
- CABG using MPS® or OPCABG
Key exclusion criteria (4 listed)
- use of other colloid solution than Cardioplexol ® for MPS®
- other inventions than CABG
- myocardial infarction <7 days before CABG
- patients denial of data use
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 |
|---|---|---|
| CABGCABG with application of a myocardial protection system (MPS ®) and using a minimal extracorporeal circulation system (MiECC) or CABG without use of a minimal extracorporeal circulation system (Off-pump coronary artery bypass grafting = OPCABG) | Procedure or surgery | MPS® in patients with CABG, OPCABG in patients with CABG |
Primary outcome
assessment of cardial biomarkers as high sensitive troponin T (hs-TrT), Creatinkinase (CK) and Creatinkinase myocardial type (CK-MB)
Time frame: perioperative during hospital stay for CABG
high sensitive troponin T (hs-TrT), Creatinkinase, (CK) Creatinkinase myocardial type (CK-MB)
3 secondary outcomes
mortality
Time frame: 30 days after CABG
need for intensive care unit
Time frame: perioperative during hospital stay for CABG
occurence of dysrhythmia
Time frame: perioperative during hospital stay for CABG
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 1 Aug 2019.
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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.
Oliver Reuthebuch, PD MD principal investigator
Klinik für Herzchirurgie, Universitätsspital Basel Spitalstrasse 21 4031 Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Coronary Artery Bypass Graft and Complication of Extracorporeal Circulation, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 Aug 2019. 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 Switzerland. 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?
assessment of cardial biomarkers as high sensitive troponin T (hs-TrT), Creatinkinase (CK) and Creatinkinase myocardial type (CK-MB) (time frame: perioperative during hospital stay for CABG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2019; AzTrials last refreshed its copy on 6 Nov 2026.