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

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Bypass Grafting
• Interventions: Device: cardiac Magnetic Resonance Imaging (MRI); Biological: Blood sample; Procedure: Cardiac muscle biopsy; Device: Holter-electrocardiogram (ECG); Other: medical examination

• Registration Number: NCT04657835
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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 .

Study Timeline

• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-12-01
• Study First Posted: 2020-12-08
• Status Verified: 2025-04
• Study Start: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-08
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Coronary Artery Bypass Grafting	medical examination	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
Coronary Artery Bypass Grafting	cardiac Magnetic Resonance Imaging (MRI)	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
Coronary Artery Bypass Grafting	Blood sample	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
Coronary Artery Bypass Grafting	Cardiac muscle biopsy	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
Coronary Artery Bypass Grafting	Holter-electrocardiogram (ECG)	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Correlation between biological parameter Interleukin 1 (IL-1) and occurrence of Post-Operative Atrial Fibrillation	Years: 2	Measured by blood sample results.
Analysis of the occurrence of Atrial Fibrillation	Year: 1	Analysis of the occurrence of Atrial Fibrillation evaluated during the first year post-operatively.
Anatomopathological parameters for the evaluation of tissue fibrosis	Year: 1	Analysis Anatomopathological parameters for the evaluation of tissue fibrosis evaluated by cardiac muscle biopsy.
Correlation between biological parameter TNF-α and occurrence of Post-Operative Atrial Fibrillation	Years: 2	Measured by blood sample results.
Assessment of Atrial Heart Disease by cardiac Magnetic Resonance Imaging (MRI) results	Before the surgery	Assessment of Atrial Heart Disease by cardiac Magnetic Resonance Imaging (MRI) results to find a correlation with Post-Operative Atrial Fibrillation.

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France