Combined Use of a Novel Cardioplegic Formula With MPS® Versus Cardioplexol ® in Urgent Isolated CABG Using MiECC in Patients With Recent Acute Myocardial Infarction

Study Overview
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Brief Summary
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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.

Official Title
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Combined Use of a Novel Cardioplegic Formula With MPS® Versus Cardioplexol ® in Urgent Isolated CABG Using MiECC in Patients With Recent Acute Myocardial Infarction

Conditions
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Heart Attack, Cardioplegia Solution Adverse Reaction, Coronary Artery Bypass Grafting (CABG)

Intervention / Treatment
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* Other: Myocardial protection system (MPS)
* Other: Cardioplexol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who underwent a CABG using MPS® or Cardioplexol ® Heart attack less than 7 days before surgery Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental<br>bypass surgery with blood cardioplegia by means of MPS | Other: Myocardial protection system (MPS)<br>* cardioplegia solution, A separate pumpsystem by which Blood cardioplegia with individually composable additives as cardioplegia solution can be used<br>|
| Active Comparator<br>bypass surgery with blood cardioplegia by means of Cardioplexol ® | Other: Cardioplexol<br>* cardioplegia solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 days Mortality | death after coronary artery bypass grafting | 30 days after CABG | 
| length of stay in the intensive care unit | duration of stay at intensive care unit | perioperative during hospital stay for CABG (for approximately 15 days) | 
| Number of participants with bleedings | bleeding complication after coronary artery bypass grafting | perioperative during hospital stay for CABG (for approximately 15 days) | 
| Number of participants with postoperative arrhythmia | rhythm disturbance after coronary artery bypass grafting | perioperative during hospital stay for CABG (for approximately 15 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart attack, cardioplegia solution, Minimal extracorporeal circulation system (MiECC), Myocardial protection system (MPS), Coronary artery bypass grafting (CABG)