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Assessment of Atrial Cardiomyopathy Using MRI as a Predictor of Cardiac Post-Operative Atrial Fibrillation After Cardiac Surgery. (IRM-FAPO)

Primary Purpose

Coronary Artery Bypass Grafting

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cardiac Magnetic Resonance Imaging (MRI)
Blood sample
Cardiac muscle biopsy
Holter-electrocardiogram (ECG)
medical examination
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Bypass Grafting focused on measuring Post Operative Atrial Fibrillation, magnetic resonance imaging, Coronary Artery Bypass Grafting (CABG)

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 18 years
  • Indication for surgical myocardial revascularization by coronary artery bypass
  • Patient affiliated or entitled to a social security scheme
  • Informed consent for participation in the study

Exclusion Criteria:

  • Contraindication to cardiac MRI (Severe Kidney disease, Allergy to gadoliniumn, ...)
  • History of Atriale Fibrillation (AF)
  • Indication of cardiac valve surgery concomitantly with Coronary Artery Bypass Grafting (CABG).
  • pregnant or breast-feeding women

Sites / Locations

  • CHU Saint-Etienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Coronary Artery Bypass Grafting

Arm Description

Patient with indication of Coronary Artery Bypass Grafting will be included. They will have: before surgery : cardiac Magnetic Resonance Imaging (MRI), Blood sample during surgery : Cardiac muscle biopsy after surgery : Holter-electrocardiogram (ECG), medical examination

Outcomes

Primary Outcome Measures

Analysis of the occurrence of Post-Operative Atrial Fibrillation
Measured by a continuous recording of cardiac electrical activity during 7 days after the surgery.

Secondary Outcome Measures

Analysis of the occurrence of Atrial Fibrillation
Analysis of the occurrence of Atrial Fibrillation evaluated during the first year post-operatively.
Anatomopathological parameters for the evaluation of tissue fibrosis
Analysis Anatomopathological parameters for the evaluation of tissue fibrosis evaluated by cardiac muscle biopsy.
Assessment of Atrial Heart Disease by cardiac Magnetic Resonance Imaging (MRI) results
Assessment of Atrial Heart Disease by cardiac Magnetic Resonance Imaging (MRI) results to find a correlation with Post-Operative Atrial Fibrillation.
Correlation between biological parameter Interleukin 1 (IL-1) and occurrence of Post-Operative Atrial Fibrillation
Measured by blood sample results.
Correlation between biological parameter TNF-α and occurrence of Post-Operative Atrial Fibrillation
Measured by blood sample results.

Full Information

First Posted
November 24, 2020
Last Updated
April 24, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT04657835
Brief Title
Assessment of Atrial Cardiomyopathy Using MRI as a Predictor of Cardiac Post-Operative Atrial Fibrillation After Cardiac Surgery.
Acronym
IRM-FAPO
Official Title
Assessment of Atrial Cardiomyopathy Using MRI as a Predictor of Cardiac Post-Operative Atrial Fibrillation After Cardiac Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2024 (Anticipated)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
After cardiac surgery, there is a high prevalence of postoperative atrial fibrillation (POAF). However, its diagnostic and therapeutic management is poorly codified. This pathology is caused by atrial abnormalities which form the concept of atrial cardiomyopathy. New tools affording to itemize the atrial cardiomyopathy are needed. Indeed, current tools, as echocardiography and electrocardiogram are relevant but only lead to a raw evaluation of the atrial cardiomyopathy. MRI, because of the assessment of the atrial fibrosis by late gadolinium assessment (LGE) and 4D flow magnetic resonance imaging (MRI) could be relevant to specify the atrial cardiomyopathy.
Detailed Description
The aim of the study is to evaluate the atrial cardiomyopathy, assessed by magnetic resonance imaging (MRI), as a predictor of postoperative atrial fibrillation (POAF) after with coronary artery bypass graft surgery .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Bypass Grafting
Keywords
Post Operative Atrial Fibrillation, magnetic resonance imaging, Coronary Artery Bypass Grafting (CABG)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coronary Artery Bypass Grafting
Arm Type
Experimental
Arm Description
Patient with indication of Coronary Artery Bypass Grafting will be included. They will have: before surgery : cardiac Magnetic Resonance Imaging (MRI), Blood sample during surgery : Cardiac muscle biopsy after surgery : Holter-electrocardiogram (ECG), medical examination
Intervention Type
Device
Intervention Name(s)
cardiac Magnetic Resonance Imaging (MRI)
Other Intervention Name(s)
4D flow Magnetic Resonance Imaging with Late Gadolinium Enhancement
Intervention Description
Cardiac magnetic resonance imaging (MRI) will be realized before Coronary Artery Bypass Grafting for assess atrial cardiomyopathy.
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention Description
Blood sample will be realized (4 tubes of 4ml blood, 16ml in total) before Coronary Artery Bypass Grafting.
Intervention Type
Procedure
Intervention Name(s)
Cardiac muscle biopsy
Intervention Description
Cardiac muscle biopsy will be realized during Coronary Artery Bypass Grafting.
Intervention Type
Device
Intervention Name(s)
Holter-electrocardiogram (ECG)
Intervention Description
Holter-electrocardiogram (ECG) will be realized 1 year after Coronary Artery Bypass Graftin during 3 days to diagnose the occurrence of atrial fibrillation.
Intervention Type
Other
Intervention Name(s)
medical examination
Intervention Description
medical examination will be realized 1 year after Coronary Artery Bypass Graftin. Theses datas will collected: events during the follow-up year and evaluation of the Holter-electrocardiogram result.
Primary Outcome Measure Information:
Title
Analysis of the occurrence of Post-Operative Atrial Fibrillation
Description
Measured by a continuous recording of cardiac electrical activity during 7 days after the surgery.
Time Frame
7 days after the surgery
Secondary Outcome Measure Information:
Title
Analysis of the occurrence of Atrial Fibrillation
Description
Analysis of the occurrence of Atrial Fibrillation evaluated during the first year post-operatively.
Time Frame
Year: 1
Title
Anatomopathological parameters for the evaluation of tissue fibrosis
Description
Analysis Anatomopathological parameters for the evaluation of tissue fibrosis evaluated by cardiac muscle biopsy.
Time Frame
Year: 1
Title
Assessment of Atrial Heart Disease by cardiac Magnetic Resonance Imaging (MRI) results
Description
Assessment of Atrial Heart Disease by cardiac Magnetic Resonance Imaging (MRI) results to find a correlation with Post-Operative Atrial Fibrillation.
Time Frame
Before the surgery
Title
Correlation between biological parameter Interleukin 1 (IL-1) and occurrence of Post-Operative Atrial Fibrillation
Description
Measured by blood sample results.
Time Frame
Years: 2
Title
Correlation between biological parameter TNF-α and occurrence of Post-Operative Atrial Fibrillation
Description
Measured by blood sample results.
Time Frame
Years: 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Indication for surgical myocardial revascularization by coronary artery bypass Patient affiliated or entitled to a social security scheme Informed consent for participation in the study Exclusion Criteria: Contraindication to cardiac MRI (Severe Kidney disease, Allergy to gadoliniumn, ...) History of Atriale Fibrillation (AF) Indication of cardiac valve surgery concomitantly with Coronary Artery Bypass Grafting (CABG). pregnant or breast-feeding women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Baptiste GUICHARD, MD
Phone
(0)4 77 82 30 77
Ext
+33
Email
j.baptiste.guichard@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fleur PETIT, CRA
Phone
(0)4.77.82.95.58
Ext
+33
Email
Fleur.petit@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste GUICHARD, MD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint-Etienne
City
Saint-Étienne
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste Guichard, MD
First Name & Middle Initial & Last Name & Degree
Antoine Da Costa, MD PhD
First Name & Middle Initial & Last Name & Degree
Kasra Azarnoush, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessment of Atrial Cardiomyopathy Using MRI as a Predictor of Cardiac Post-Operative Atrial Fibrillation After Cardiac Surgery.

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