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

Coronary Artery Bypass Grafting Clinical Trial

— IRM-FAPO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04657835
• Other study ID #: 20CH027
• Secondary ID: 2020-A01632-37
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: August 2026

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Jean-Baptiste GUICHARD, MD
• Phone: (0)4 77 82 30 77
• Email: j.baptiste.guichard[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiomyopathies
• Coronary Artery Bypass Grafting

Intervention

Device:
• cardiac Magnetic Resonance Imaging (MRI)
Cardiac magnetic resonance imaging (MRI) will be realized before Coronary Artery Bypass Grafting for assess atrial cardiomyopathy.

Biological:
• Blood sample
Blood sample will be realized (4 tubes of 4ml blood, 16ml in total) before Coronary Artery Bypass Grafting.

Procedure:
• Cardiac muscle biopsy
Cardiac muscle biopsy will be realized during Coronary Artery Bypass Grafting.

Device:
• Holter-electrocardiogram (ECG)
Holter-electrocardiogram (ECG) will be realized 1 year after Coronary Artery Bypass Graftin during 3 days to diagnose the occurrence of atrial fibrillation.

Other:
• medical examination
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.

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of the occurrence of Post-Operative Atrial Fibrillation	Measured by a continuous recording of cardiac electrical activity during 7 days after the surgery.	7 days after the surgery
Secondary	Analysis of the occurrence of Atrial Fibrillation	Analysis of the occurrence of Atrial Fibrillation evaluated during the first year post-operatively.	Year: 1
Secondary	Anatomopathological parameters for the evaluation of tissue fibrosis	Analysis Anatomopathological parameters for the evaluation of tissue fibrosis evaluated by cardiac muscle biopsy.	Year: 1
Secondary	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.	Before the surgery
Secondary	Correlation between biological parameter Interleukin 1 (IL-1) and occurrence of Post-Operative Atrial Fibrillation	Measured by blood sample results.	Years: 2
Secondary	Correlation between biological parameter TNF-a and occurrence of Post-Operative Atrial Fibrillation	Measured by blood sample results.	Years: 2