Heart AttackNCT04309994
Combined Use of a Novel Cardioplegic Formula With MPS® Versus Cardioplexol ® in Urgent Isolated CABG Using MiECC in Patients With Recent Acute Myocardial Infarction
An observational study of Heart Attack and Cardioplegia Solution Adverse Reaction, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The goal of this study is to compare the two cardioplegia solutions (blood cardioplegia by means of MPS ® vs. Cardioplexol ®) regarding perioperative outcome and with special attention to cardiac markers in patients with a recent heart attack. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Attack, Cardioplegia Solution Adverse Reaction, Coronary Artery Bypass Grafting (CABG)
- What is being tested?
- Myocardial protection system (MPS) and Cardioplexol
- How many people
- 307 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2010to Jan 2020
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients which underwent isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation system) at the department of cardial surgery University Hospital Basel Switzerland
Who may be able to join
- Patients who underwent a CABG using MPS® or Cardioplexol ®
- Heart attack less than 7 days before surgery
Who cannot join
- use of other cardioplegia solution than Cardioplexol ® or MPS®
- other inventions than CABG
- explicit will of the patient that his data may not be used
- denied general consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Cardiac Surgery Clinic University Hospital Basel
Basel, 4031
About this study
The goal of this study is to compare the two cardioplegia solutions (blood cardioplegia by means of MPS ® vs. Cardioplexol ®) regarding perioperative outcome and with special attention to cardiac markers in patients with a recent heart attack.
- Conditions
- Heart Attack, Cardioplegia Solution Adverse Reaction, Coronary Artery Bypass Grafting (CABG)
- Being tested
- Myocardial protection system (MPS), Cardioplexol
- Keywords
- heart attack, cardioplegia solution, Minimal extracorporeal circulation system (MiECC), Myocardial protection system (MPS), Coronary artery bypass grafting (CABG)
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myocardial protection system (MPS)Other
cardioplegia solution, A separate pumpsystem by which Blood cardioplegia with individually composable additives as cardioplegia solution can be used
CardioplexolOther
cardioplegia solution
| Study group | Role | What they receive |
|---|---|---|
| Experimental | bypass surgery with blood cardioplegia by means of MPS Receives: Other: Myocardial protection system (MPS) | |
| Active Comparator | bypass surgery with blood cardioplegia by means of Cardioplexol ® Receives: Other: Cardioplexol |
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial damage
Analyse cardiac biomarkers as indicators for myocardial damage: high sensitive troponin (Ths-TrT, ng/mL), creatine kinase (CK, in ng/mL) and creatine kinase-MB isoenzyme (CK-MB, in ng/mL)
Measured: patients with that received a coronary artery bypass grafting and that were treated (for approximately 15 days) at the University Hospital between February 2010 and January 2020 (data taken perioperative during hospital stay for CABG)
Secondary outcomes (4)
30 days Mortality
death after coronary artery bypass grafting
Measured: 30 days after CABG
length of stay in the intensive care unit
duration of stay at intensive care unit
Measured: perioperative during hospital stay for CABG (for approximately 15 days)
Number of participants with bleedings
bleeding complication after coronary artery bypass grafting
Measured: perioperative during hospital stay for CABG (for approximately 15 days)
Number of participants with postoperative arrhythmia
rhythm disturbance after coronary artery bypass grafting
Measured: perioperative during hospital stay for CABG (for approximately 15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Feb 2010
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart AttackStudies 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
- Retrospective
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver Reuthebuch, Prof. Dr. med., Principal investigator, Cardiac Surgery Clinic, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309994
- Sponsor's protocol ID
- 2019-02383; ch20Reuthebuch
- Other IDs
- 2019
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 17 Mar 2020
- 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 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Use of a Novel Cardioplegic Formula With MPS® Versus Cardioplexol ® in Urgent Isolated CABG Using MiECC in Patients With Recent Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04309994
- Acronym / sponsor ID
- 2019-02383; ch20Reuthebuch
- Conditions
- Heart Attack, Cardioplegia Solution Adverse Reaction, Coronary Artery Bypass Grafting (CABG)
- Keywords
- heart attack, cardioplegia solution, Minimal extracorporeal circulation system (MiECC), Myocardial protection system (MPS), Coronary artery bypass grafting (CABG)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Feb 2010 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 17 Mar 2020 (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 goal of this study is to compare the two cardioplegia solutions (blood cardioplegia by means of MPS ® vs. Cardioplexol ®) regarding perioperative outcome and with special attention to cardiac markers in patients with a recent heart attack.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Other: Myocardial protection system (MPS)bypass surgery with blood cardioplegia by means of MPS |
| Active Comparator | – | Other: Cardioplexolbypass surgery with blood cardioplegia by means of Cardioplexol ® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients which underwent isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation system) at the department of cardial surgery University Hospital Basel Switzerland
Key inclusion criteria (2 listed)
- Patients who underwent a CABG using MPS® or Cardioplexol ®
- Heart attack less than 7 days before surgery
Key exclusion criteria (4 listed)
- use of other cardioplegia solution than Cardioplexol ® or MPS®
- other inventions than CABG
- explicit will of the patient that his data may not be used
- denied general 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 |
|---|---|---|
| Myocardial protection system (MPS)cardioplegia solution, A separate pumpsystem by which Blood cardioplegia with individually composable additives as cardioplegia solution can be used | Other | Experimental |
| Cardioplexolcardioplegia solution | Other | Active Comparator |
Primary outcome
myocardial damage
Time frame: patients with that received a coronary artery bypass grafting and that were treated (for approximately 15 days) at the University Hospital between February 2010 and January 2020 (data taken perioperative during hospital stay for CABG)
Analyse cardiac biomarkers as indicators for myocardial damage: high sensitive troponin (Ths-TrT, ng/mL), creatine kinase (CK, in ng/mL) and creatine kinase-MB isoenzyme (CK-MB, in ng/mL)
4 secondary outcomes
30 days Mortality
Time frame: 30 days after CABG
length of stay in the intensive care unit
Time frame: perioperative during hospital stay for CABG (for approximately 15 days)
Number of participants with bleedings
Time frame: perioperative during hospital stay for CABG (for approximately 15 days)
Number of participants with postoperative arrhythmia
Time frame: perioperative during hospital stay for CABG (for approximately 15 days)
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 17 Mar 2020.
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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, Prof. Dr. med. principal investigator
Cardiac Surgery Clinic, University Hospital 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 Heart Attack and Cardioplegia Solution Adverse Reaction, 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 2 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 17 Mar 2020. 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?
myocardial damage (time frame: patients with that received a coronary artery bypass grafting and that were treated (for approximately 15 days) at the University Hospital between February 2010 and January 2020 (data taken 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 17 Mar 2020.