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

March 3, 2026 updated by: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Saint-Etienne, France, 42055
        • Chu Saint-Etienne
        • Principal Investigator:
          • Karim BENALI, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Antoine DA COSTA, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Device: 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.
Other Names:
  • 4D flow Magnetic Resonance Imaging with Late Gadolinium Enhancement
Biological: 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).
Device: 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.

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the predictive value of atrial heart disease characterized by multiparametric MRI (late enhancement fibrosis, atrial strain, and exploratory 4D flow parameters) for the recurrence of atrial fibrillation documented by Implantable Loop Recorder.
Time Frame: through study completion, an average of 12 months
Recurrence of atrial fibrillation, defined as an episode lasting ≥ 30 seconds documented by the Implantable Loop Recorder (ILR) implanted preoperatively and recorded during the 12-month follow-up period.
through study completion, an average of 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the link between atrial heart disease characterized by MRI (fibrosis, strain, 4D flow) and the occurrence of postoperative atrial fibrillation (POAF) during the first week following coronary artery bypass grafting.
Time Frame: through the first postoperative week
POAF will be defined as an episode of AF ≥ 30 seconds, detected by the preoperatively implanted ILR and recorded during the first postoperative week.
through the first postoperative week
Correlate MRI parameters of atrial remodeling with histological assessment of fibrosis on intraoperative atrial biopsy
Time Frame: through the first postoperative week
Percentage of histological fibrosis. Analysis of atrial fibrosis using Masson's trichrome staining on intraoperative atrial biopsy (normal threshold ≤ 10%). The objective is to establish a correlation between histological data and MRI parameters.
through the first postoperative week
Exploring the value of atrial hemodynamic parameters obtained by 4D flow MRI (vorticity, intra-atrial velocities) as predictive markers of atrial fibrillation
Time Frame: Before the surgery
measurement of intra-auricular blood flow using 4D-flow MRI, including velocities (cm/s), flow volumes (mL/s or mL), and vorticity indices (s-¹)
Before the surgery
To study the association between serum inflammatory biomarkers (CRP, IL-1, TNF-α) and Atrial Fibrillation recurrence.
Time Frame: before the surgery
Preoperative measurement of pro-inflammatory cytokines (IL-1, TNF-α, CRP).
before the surgery
Determine the impact of atrial fibrillation recurrence documented by ILR on the occurrence of major cardiovascular events
Time Frame: through study completion, an average of 12 months
Number of ischemic strokes, hospitalizations for heart failure, cardiovascular deaths occurring within one year of surgery, and all-cause deaths.
through study completion, an average of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Study Director: Jean-Baptiste GUICHARD, MD, Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

November 24, 2020

First Submitted That Met QC Criteria

December 1, 2020

First Posted (Actual)

December 8, 2020

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20CH027
  • ANSM (Other Identifier: 2026-A00172-49)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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