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

Primary Purpose

Heart Arrest

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Antegrade cardioplegia
Retrograde cardioplegia
Sponsored by
Brugmann University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Arrest focused on measuring PV-loops (pressure-volume loops), Myocardial contractility, Cardioplegia, Induced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Valvulopathy
  • Associated procedures

Sites / Locations

  • CHU Brugmann

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Antegrade Cardioplegia

Retrograde Cardioplegia

Arm Description

Coronary artery bypass grafting (CABG) surgery in patients with a normal left ventricular ejection fraction (FEVG)

Coronary artery bypass grafting (CABG) surgery in patients with a normal left ventricular ejection fraction (FEVG)

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Troponin post operative level
The investigators would like to measure post operative troponin levels as a biological marker of myocardial protection
Troponin post operative level
The investigators would like to measure post operative troponin as a biological marker of myocardial protection.
Troponin post operative level
The investigators would like to measure post operative troponin as a biological marker of myocardial protection.

Full Information

First Posted
April 20, 2016
Last Updated
November 20, 2017
Sponsor
Brugmann University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02816385
Brief Title
Study of Myocardial Contractility After Cardiac Surgery Under an Anterograde or Retrograde Cardioplegia
Official Title
Study of Myocardial Contractility After Cardiac Surgery Under an Anterograde or Retrograde Cardioplegia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Arrest
Keywords
PV-loops (pressure-volume loops), Myocardial contractility, Cardioplegia, Induced

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antegrade Cardioplegia
Arm Type
Active Comparator
Arm Description
Coronary artery bypass grafting (CABG) surgery in patients with a normal left ventricular ejection fraction (FEVG)
Arm Title
Retrograde Cardioplegia
Arm Type
Experimental
Arm Description
Coronary artery bypass grafting (CABG) surgery in patients with a normal left ventricular ejection fraction (FEVG)
Intervention Type
Procedure
Intervention Name(s)
Antegrade cardioplegia
Intervention Description
Injection of the cardioplegia in the coronary arteries
Intervention Type
Procedure
Intervention Name(s)
Retrograde cardioplegia
Intervention Description
Injection of the cardioplegia in the venous system
Primary Outcome Measure Information:
Title
Contractility index of the right ventricle
Description
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.
Time Frame
Baseline
Title
Contractility index of the right ventricle
Description
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.
Time Frame
immediately after discontinuation of the extracorporeal blood circulation (end of cardiac surgery according to standard of care - up to 4h)
Title
Contractility index of the right ventricle
Description
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.
Time Frame
10 minutes after discontinuation of the extracorporeal blood circulation
Title
Contractility index of the right ventricle
Description
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.
Time Frame
20 minutes after discontinuation of the extracorporeal blood circulation
Secondary Outcome Measure Information:
Title
Troponin post operative level
Description
The investigators would like to measure post operative troponin levels as a biological marker of myocardial protection
Time Frame
6h post surgery
Title
Troponin post operative level
Description
The investigators would like to measure post operative troponin as a biological marker of myocardial protection.
Time Frame
12h post surgery
Title
Troponin post operative level
Description
The investigators would like to measure post operative troponin as a biological marker of myocardial protection.
Time Frame
24h post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Need for myocardial revascularisation Normal FEVG ( > 50%) Exclusion Criteria: Valvulopathy Associated procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Wauthy, MD, Pr
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alessandro Falchetti, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium

12. IPD Sharing Statement

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

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