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

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.

Study Overview

• Status: Completed
• Conditions: Heart Arrest
• Intervention / Treatment: Procedure: Antegrade cardioplegia; Procedure: Retrograde cardioplegia

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • CHU Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Valvulopathy
• Associated procedures

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brugmann University Hospital
• Investigators: Principal Investigator: Pierre Wauthy, MD, Pr, CHU Brugmann; Principal Investigator: Alessandro Falchetti, MD, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: April 20, 2016
• First Submitted That Met QC Criteria: June 24, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): November 22, 2017
• Last Update Submitted That Met QC Criteria: November 20, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Cardioplegia; Induced; Myocardial contractility; PV-loops (pressure-volume loops)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: CHUB-Retroplegie