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

Heart Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816385
• Other study ID #: CHUB-Retroplegie
• Status: Completed
• Phase: N/A
• First received: April 20, 2016
• Last updated: November 20, 2017
• Start date: September 2016
• Est. completion date: November 2017

Study information

• Verified date: November 2017
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Need for myocardial revascularisation

• Normal FEVG ( > 50%)

Exclusion Criteria:

• Valvulopathy

• Associated procedures

Related Conditions & MeSH terms

• Heart Arrest

Intervention

Procedure:
• Antegrade cardioplegia
Injection of the cardioplegia in the coronary arteries
• Retrograde cardioplegia
Injection of the cardioplegia in the venous system

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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
Primary	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	Troponin post operative level	The investigators would like to measure post operative troponin levels as a biological marker of myocardial protection	6h post surgery
Secondary	Troponin post operative level	The investigators would like to measure post operative troponin as a biological marker of myocardial protection.	12h post surgery
Secondary	Troponin post operative level	The investigators would like to measure post operative troponin as a biological marker of myocardial protection.	24h post surgery