Korodi Szilamer, Toganel Rodica, Benedek Theodora, Hodas Roxana, Chitu Monica, Ratiu Mihaela, Kovacs Istvan, Mester Andras, Benedek Imre
University of Medicine, Pharmacy, Sciences and Technology.
Department of Advanced Research in Multimodality Cardiovascular Imaging, Cardio Med Medical Center.
Medicine (Baltimore). 2019 Mar;98(9):e14504. doi: 10.1097/MD.0000000000014504.
Interventional ablation has been demonstrated to represent an effective therapy in patients with atrial fibrillation (AF), leading to restoration and maintenance of sinus rhythm in the majority of cases. However, recurrence of AF is encountered in 35% to 40% of cases, and the causes for this frequent complication have not been elucidated so far.
Here we present the study protocol of the FIBRO-RISK trial, a prospective, single-center, cohort study which aims to investigate the impact of inflammatory-mediated myocardial fibrosis on the risk of recurrence after successful catheter ablation of atrial fibrillation. The level of systemic inflammation in the pre-ablation and immediate post-ablation period will be assessed on the basis of serum levels of inflammatory biomarkers (hsCRP, matrix metalloproteases, interleukin-6), while the level of cardiac fibrosis will be determined based on cardiac magnetic resonance imaging associated with complex post-processing techniques for mapping myocardial fibrosis at the level of left atrium and left ventricle. At the same time, the amount of epicardial fat will serve as an indirect marker of localized inflammation and will be determined at different levels in the heart (surrounding left atrium, right atrium or the entire heart), while ventricular function will be assessed on the basis of serum levels of NT-proBNP prior to the procedure. All these parameters will be investigated in patients with successful ablation of AF, who will be divided into 2 groups: group 1 - patients who develop AF recurrence at 1-year, and group 2 - patients with no recurrence of AF at 1-year. In all patients, the following biomarkers will be determined: serum levels of inflammatory biomarkers and NT-proBNP at 24 hours and 1-year post procedure, the amount of myocardial fibrosis at the level of left atrium and left ventricle at baseline +/- 7 days, and the amount of epicardial fat surrounding left atrium, right atrium and the entire heart at baseline +/- 7 days.The primary endpoint of the study will be represented by the rate of AF recurrence at 1-year post ablation, documented by either ECG or Holter monitoring. The secondary endpoints of the study will consist in:In conclusion, FIBRO-RISK will be the first CMR-based study that will investigate the impact of inflammation-mediated myocardial fibrosis and ventricular remodeling on the risk of recurrence after successful ablation of AF, aiming to validate inflammatory biomarkers and myocardial fibrosis as predictors for AF recurrence.
介入消融已被证明是心房颤动（AF）患者的一种有效治疗方法，在大多数情况下可导致窦性心律的恢复和维持。然而，35%至40%的病例会出现房颤复发，迄今为止，这种常见并发症的原因尚未阐明。
在此，我们介绍FIBRO-RISK试验的研究方案，这是一项前瞻性、单中心队列研究，旨在调查炎症介导的心肌纤维化对房颤成功导管消融术后复发风险的影响。消融前和消融后即刻的全身炎症水平将根据炎症生物标志物（高敏C反应蛋白、基质金属蛋白酶、白细胞介素-6）的血清水平进行评估，而心脏纤维化水平将基于心脏磁共振成像并结合用于绘制左心房和左心室水平心肌纤维化的复杂后处理技术来确定。同时，心外膜脂肪量将作为局部炎症的间接标志物，并将在心脏的不同水平（围绕左心房、右心房或整个心脏）进行测定，而心室功能将在手术前根据血清NT-proBNP水平进行评估。所有这些参数将在房颤成功消融的患者中进行研究，这些患者将分为两组：第1组 - 1年内发生房颤复发的患者，第2组 - 1年内无房颤复发的患者。在所有患者中，将测定以下生物标志物：术后24小时和1年时炎症生物标志物和NT-proBNP的血清水平、基线±7天时左心房和左心室水平的心肌纤维化量，以及基线±7天时围绕左心房、右心房和整个心脏的心外膜脂肪量。该研究的主要终点将由消融后1年的房颤复发率表示，通过心电图或动态心电图监测记录。该研究的次要终点将包括：总之，FIBRO-RISK将是第一项基于CMR的研究，该研究将调查炎症介导的心肌纤维化和心室重构对房颤成功消融术后复发风险的影响，旨在验证炎症生物标志物和心肌纤维化作为房颤复发预测指标的有效性。
