Multiparametric MRI Assessment of Atrial Heart Disease as a Predictor of Atrial Fibrillation After Myocardial Revascularization Surgery (IRM-FAPO)

Centre Hospitalier Universitaire de Saint Etienne

Status: Begins enrollment this month

Conditions: Postoperative Atrial Fibrillation

Treatments: Biological: Blood sample; Device: 4D cardiac MRI with gadoteric acid; Procedure: Right atrial biopsy; Device: Implantable Loop Recorder (ILR)

Study type: Interventional

Funder types: Other

Identifiers

NCT04657835

20CH027

ANSM (Other Identifier)

Details and patient eligibility

About

Postoperative atrial fibrillation (POAF) occurs in 20-40% of patients undergoing coronary artery bypass grafting (CABG) and is a marker of atrial vulnerability. It is strongly associated with AF recurrence, stroke, and cardiovascular mortality. It presents risk factors with atrial heart disease.

The latter refers to all structural, electrical, and mechanical alterations of the atrium that create a substrate conducive to AF.

Multiparametric cardiac MRI is currently the most comprehensive test for assessing atrial heart disease, thanks to its structural and functional analysis (atrial fibrosis, atrial strain, intracavitary 4D flow). However, to date, no prospective study has evaluated these parameters as predictors of AF recurrence after CAP. At the same time, an implantable Holter monitor will be used to enable detailed and continuous detection of recurrence episodes, overcoming the limitations of conventional monitoring strategies. By combining multiparametric imaging, histological analysis, and continuous monitoring for the first time, this study proposes a paradigm shift in the assessment of postoperative AF: moving from a descriptive and ad hoc approach to a mechanistic, integrative, and predictive approach.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Indication for surgical myocardial revascularization by isolated coronary artery bypass grafting, to be performed in the cardiac surgery department of Saint-Étienne University Hospital.
• Patient affiliated with or entitled to social security coverage
• Patient who has received informed information about the study and has co-signed, with the investigator, a consent form to participate in the study

Exclusion criteria

• Contraindication related to cardiac MRI
• Contraindication related to ILR implantation
• Documented history of atrial fibrillation
• Concomitant indication for valve surgery or other associated cardiac intervention
• Inability to understand French
• Patient refusal to participate in the study and/or inability to express consent or sign the informed consent form
• Patient subject to legal protection measures

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Myocardial revascularization cardiac surgery by coronary artery bypass grafting

Experimental group

Description:

Patient with indication of Coronary Artery Bypass Grafting will be included. They will have: * before surgery : 4D cardiac MRI with gadoteric acid + ILR implantation + blood sampling * during surgery : right atrial biopsy * after surgery : Continuous monitoring by ILR for 12 months + scheduled clinical consultation (at 12 months)

Treatment:

Device: Implantable Loop Recorder (ILR)

Procedure: Right atrial biopsy

Device: 4D cardiac MRI with gadoteric acid

Biological: Blood sample