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

Not Applicable

Completed

• Conditions: Heart Arrest
• Interventions: Procedure: Antegrade cardioplegia; Procedure: Retrograde cardioplegia

• Registration Number: NCT02816385
• Lead Sponsor: Brugmann University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-28
• Study Start: 2016-09
• Status Verified: 2017-11
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Last Update Submitted: 2017-11-20
• Last Update Posted: 2017-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Need for myocardial revascularisation
• Normal FEVG ( > 50%)

Exclusion Criteria

• Valvulopathy
• Associated procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antegrade Cardioplegia	Antegrade cardioplegia	Coronary artery bypass grafting (CABG) surgery in patients with a normal left ventricular ejection fraction (FEVG)
Retrograde Cardioplegia	Retrograde cardioplegia	Coronary artery bypass grafting (CABG) surgery in patients with a normal left ventricular ejection fraction (FEVG)

Primary Outcome Measures

Name	Time	Method
Contractility index of the right ventricle	20 minutes after discontinuation of the extracorporeal blood circulation	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.

Secondary Outcome Measures

Name	Time	Method
Troponin post operative level	24h post surgery	The investigators would like to measure post operative troponin as a biological marker of myocardial protection.

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussels, Belgium