Ireland
--:--IST
Latest
Clinical Trials in France / NCT04657835
Starting soon Not applicable

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

NCT04657835 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-05-01
Last updated
2026-03-05

Condition(s) studied

Postoperative Atrial Fibrillation

Investigational drug(s) / intervention(s)

4D cardiac MRI with gadoteric acidBlood sample →Implantable Loop Recorder (ILR)Right atrial biopsy

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.

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).

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CHU Saint-Etienne Saint-Etienne France

More Centre Hospitalier Universitaire de Saint Etienne trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04657835 on ClinicalTrials.gov ↗ ← All trials in France