NCT04657835

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2020-12-08
• Last updated: 2026-03-05

Locations

1 site across 1 country: France