Multiparametric MRI Assessment of Atrial Heart Disease as a Predictor of Atrial Fibrillation After Myocardial Revascularization Surgery

NCT ID: NCT04657835

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2029-03-02

Brief Summary

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.

Conditions

Postoperative Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Myocardial revascularization cardiac surgery by coronary artery bypass grafting

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)

Group Type: EXPERIMENTAL

4D cardiac MRI with gadoteric acid

Intervention Type: DEVICE

4D cardiac MRI with gadoteric acid injection will be performed prior the surgery, according to a standardized technical protocol.

Blood sample

Intervention Type: BIOLOGICAL

Peripheral venous blood sample (1 x 6 ml EDTA tube): taken during preoperative assessment to measure inflammatory biomarkers (CRP, IL-1, TNF-α).

Implantable Loop Recorder (ILR)

Intervention Type: DEVICE

Implantation of a Holter monitor (Implantable Loop Recorder) prior to surgery, performed preoperatively under local anesthesia.

The ILR will enable continuous recording of the heart rhythm for 12 months with automatic data transmission via remote monitoring. The minimally invasive procedure will be performed by an experienced cardiologist under the usual safety conditions.

Right atrial biopsy

Intervention Type: PROCEDURE

During the surgical procedure (coronary artery bypass grafting), a right atrial biopsy will be performed using a brief, low-risk procedure on a small tissue sample. The sample will be analyzed using Masson's trichrome staining to assess atrial fibrosis.

Interventions

4D cardiac MRI with gadoteric acid

4D cardiac MRI with gadoteric acid injection will be performed prior the surgery, according to a standardized technical protocol.

Intervention Type: DEVICE

Blood sample

Peripheral venous blood sample (1 x 6 ml EDTA tube): taken during preoperative assessment to measure inflammatory biomarkers (CRP, IL-1, TNF-α).

Intervention Type: BIOLOGICAL

Implantable Loop Recorder (ILR)

Implantation of a Holter monitor (Implantable Loop Recorder) prior to surgery, performed preoperatively under local anesthesia.

The ILR will enable continuous recording of the heart rhythm for 12 months with automatic data transmission via remote monitoring. The minimally invasive procedure will be performed by an experienced cardiologist under the usual safety conditions.

Intervention Type: DEVICE

Right atrial biopsy

During the surgical procedure (coronary artery bypass grafting), a right atrial biopsy will be performed using a brief, low-risk procedure on a small tissue sample. The sample will be analyzed using Masson's trichrome staining to assess atrial fibrosis.

Intervention Type: PROCEDURE

Other Intervention Names

4D flow Magnetic Resonance Imaging with Late Gadolinium Enhancement

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Baptiste GUICHARD, MD

Role: STUDY_DIRECTOR

Hospital Clinic of Barcelona

Locations

CHU Saint-Etienne

Saint-Etienne, , France

Countries

France

Central Contacts

Karim Benali, MD

Role: CONTACT

karim.benali@chu-st-etienne.fr

(0)477828679 ext. +33

Facility Contacts

Karim BENALI, MD

Role: primary

karim.benali@chu-st-etienne.fr

(0)477828679 ext. +33

Jean-Baptiste GUICHARD, MD

Role: backup

jbguichard@clinic.cat

Other Identifiers

ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

20CH027

Identifier Type: -

Identifier Source: org_study_id