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

Обзор

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.

Вмешательства

• Устройство 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.
• Биопрепарат 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).
• Устройство 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.
• Процедура 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.

Первичные конечные точки

• 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. [Срок оценки: through study completion, an average of 12 months]

Вторичные конечные точки (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. [Срок оценки: through the first postoperative week]
• Correlate MRI parameters of atrial remodeling with histological assessment of fibrosis on intraoperative atrial biopsy [Срок оценки: 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 [Срок оценки: Before the surgery]
• To study the association between serum inflammatory biomarkers (CRP, IL-1, TNF-α) and Atrial Fibrillation recurrence. [Срок оценки: before the surgery]
• Determine the impact of atrial fibrillation recurrence documented by ILR on the occurrence of major cardiovascular events [Срок оценки: through study completion, an average of 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• CHU Saint-Etienne — Saint-Etienne

Идентификаторы

NCT: NCT04657835 · 20CH027 · ANSM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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