Multiparametric MRI Assessment of Atrial Heart Disease as a Predictor of Atrial Fibrillation After Myocardial Revascularization Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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)
干预措施: 4D cardiac MRI with gadoteric acid (Device)
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)
干预措施: Blood sample (Biological)
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)
干预措施: Implantable Loop Recorder (ILR) (Device)
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)
干预措施: Right atrial biopsy (Procedure)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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)