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

NCT04657835 | Not Yet Recruiting

• 2 other identifiers: 20CH027ANSM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

magnetic resonance imaging; implantable holter monitor; atrial heart disease

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (5)

• 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.

  through the first postoperative week

• Correlate MRI parameters of atrial remodeling with histological assessment of fibrosis on intraoperative atrial biopsy

  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

  Before the surgery

• To study the association between serum inflammatory biomarkers (CRP, IL-1, TNF-α) and Atrial Fibrillation recurrence.

  before the surgery

• Determine the impact of atrial fibrillation recurrence documented by ILR on the occurrence of major cardiovascular events

  through study completion, an average of 12 months

Study Arms (1)

Myocardial revascularization cardiac surgery by coronary artery bypass grafting

EXPERIMENTAL

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; Biological: Blood sample; Device: Implantable Loop Recorder (ILR); Procedure: Right atrial biopsy

Interventions

4D cardiac MRI with gadoteric acid DEVICE

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

Also known as: 4D flow Magnetic Resonance Imaging with Late Gadolinium Enhancement

Myocardial revascularization cardiac surgery by coronary artery bypass grafting

Blood sample BIOLOGICAL

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

Myocardial revascularization cardiac surgery by coronary artery bypass grafting

Implantable Loop Recorder (ILR) 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.

Myocardial revascularization cardiac surgery by coronary artery bypass grafting

Right atrial biopsy 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.

Myocardial revascularization cardiac surgery by coronary artery bypass grafting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jean-Baptiste GUICHARD, MD

  Hospital Clinic of Barcelona

  STUDY DIRECTOR

Central Study Contacts

Karim Benali, MD

CONTACT

(0)477828679; karim.benali@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective single-center pilot study

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 8, 2020
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)