Study of Myocardial Contractility After Cardiac Surgery Under an Anterograde or Retrograde Cardioplegia

Study Overview
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Brief Summary
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Myocardial protection is a fundamental element for the safety of patients when performing cardiac surgery. For this purpose, cardioplegia were rapidly established in clinical practice to protect the myocardium when performing aortic clamp. Cardioplegia are procedures to stop the contraction of myocardium. It is usually achieved with the use of chemicals ( cardioplegic solutions) or cold temperature (such as chilled perfusate). The composition of the cardioplegic solutions and their method of administration continuously changed over the years. At the present date, cold blood cardioplegias are performed in the investigator's center. The investigators regularly use two modes of administration: either by an antegrade path (injection in the coronary arteries), or a retrograde one (injection in the venous system). At present, there are no elements supporting the superiority or inferiority of one path compared to another. The difficulty lies within a clear estimation of the contractility state of the ventricular cardiac muscle. Technological developments in recent years provided a solution to this problem. The analysis of the pressure/volume curves generated by a ventricle allows an accurate quantification of the myocardial contractility. This requires the use of conductance catheters to accurately measure the ventricular volume and the ventricular pressure. The absolute ventricular contractility is then deduced with the help of a software. The investigators intend to use this pressure-volume loops, obtained with conductance catheters, to compare the contractility of the right heart ventricle after antegrade vs retrograde cardioplegia.

Official Title
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Study of Myocardial Contractility After Cardiac Surgery Under an Anterograde or Retrograde Cardioplegia

Conditions
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Heart Arrest

Intervention / Treatment
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* Procedure: Antegrade cardioplegia
* Procedure: Retrograde cardioplegia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Need for myocardial revascularisation Normal FEVG ( > 50%) Exclusion Criteria: Valvulopathy Associated procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antegrade Cardioplegia<br>Coronary artery bypass grafting (CABG) surgery in patients with a normal left ventricular ejection fraction (FEVG) | Procedure: Antegrade cardioplegia<br>* Injection of the cardioplegia in the coronary arteries<br>|
| Experimental: Retrograde Cardioplegia<br>Coronary artery bypass grafting (CABG) surgery in patients with a normal left ventricular ejection fraction (FEVG) | Procedure: Retrograde cardioplegia<br>* Injection of the cardioplegia in the venous system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contractility index of the right ventricle | Cardiac surgery is performed according to the standard of care. The intraventricular pressure and the ventricular volume, measured with a conductance catheter, are combined within a software to compute the contractility index of the right ventricle. The baseline measure will be performed before the instauration of the extracorporeal blood circulation, during the cardiac surgery. | Baseline | 
| Contractility index of the right ventricle | Cardiac surgery is performed according to the standard of care. The intraventricular pressure and the ventricular volume, measured with a conductance catheter, are combined within a software to compute the contractility index of the right ventricle. This will be measured at the end of the cardiac surgery, immediately after discontinuation of the extracorporeal circulation, with absence of inotropic support. | immediately after discontinuation of the extracorporeal blood circulation (end of cardiac surgery according to standard of care - up to 4h) | 
| Contractility index of the right ventricle | Cardiac surgery is performed according to the standard of care. The intraventricular pressure and the ventricular volume, measured with a conductance catheter, are combined within a software to compute the contractility index of the right ventricle. This will be measured at the end of the cardiac surgery, 10 minutes after discontinuation of the extracorporeal circulation, with absence of inotropic support. | 10 minutes after discontinuation of the extracorporeal blood circulation | 
| Contractility index of the right ventricle | Cardiac surgery is performed according to the standard of care. The intraventricular pressure and the ventricular volume, measured with a conductance catheter, are combined within a software to compute the contractility index of the right ventricle. This will be measured at the end of the cardiac surgery, 20 minutes after discontinuation of the extracorporeal circulation, with absence of inotropic support. | 20 minutes after discontinuation of the extracorporeal blood circulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Troponin post operative level | The investigators would like to measure post operative troponin levels as a biological marker of myocardial protection | 6h post surgery | 
| Troponin post operative level | The investigators would like to measure post operative troponin as a biological marker of myocardial protection. | 12h post surgery | 
| Troponin post operative level | The investigators would like to measure post operative troponin as a biological marker of myocardial protection. | 24h post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PV-loops (pressure-volume loops), Myocardial contractility, Cardioplegia, Induced