Contribution of Left Atrial Epicardial Fat Quantification by Computed Tomography and Left Atrial Strain by MRI in Atrial-Fibrilation Ablation: "The CTStrain-AF Study"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Prognostic value of automated measurement of epicardial fat in CT and and total left atrial strain in MRI
研究概览
简要总结
Atrial fibrillation ablation (AF) is a standard interventional treatment for patients with symptomatic AF refractory to medical treatment. The known predictive factors for the success of the procedure remain insufficient to predict the probabilities of success and to appropriately select the patients who could benefit the most from this procedure. Left atrium imaging by MRI or CT may be able to identify AF substrate. However data are lacking about the practical impact of these techniques in routine practice to predict AF ablation outcome.
The "CT-AF" study is a prospective, interventional, multicenter cohort study. The main objective of this study is to evaluate the prognostic value of a new automated measurement technique for intra-myocardial atrial fat measurement in cardiac CT and the measurement of global left atrial strain in MRI in patients who are candidates for first AF ablation.
The main outcome will be the relationship between the relative volume of left atrial fat measured with CT and total left atrial strain in MRI and recurrence of AF at 1 year after the ablation procedure (blanking period of 3 months post ablation excluded).
详细描述
Scientific background :
Atrial fibrillation ablation (AF) is a standard interventional treatment for patients with symptomatic AF refractory to medical treatment. The known predictive factors for the success of the procedure remain insufficient to predict the probabilities of success and to appropriately select the patients who could benefit the most from this invasive procedure. Previous studies have shown that the quantification of atrial fibrosis in magnetic resonance imaging (MRI) may be a good marker of atrial remodeling and would reliably predict the chances of success of the ablation procedure. Nevertheless, the use of this technique is very limited in routine because of the complexity of quantitative analysis and spatial resolution limits. The association of fibrosing processes within epicardial fat has been established. The characterization of epicardial fat in CT could be a relevant substitute for the direct characterization of fibrosis. This examination was essential for the study of atrial anatomy before ablation of AF. In addition to the anatomical evaluation, the study of sub-epicardial fat by cardiac CT could therefore be an interesting approach for evaluating the AF substrate.
Main objective:
To evaluate the prognostic value of a new automated measurement technique for intra-myocardial atrial fat measurement in cardiac CT and the measurement of global left atrial strain in MRI in patients who are candidates for first AF ablation.
Secondary objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient in whom radiofrequency AF ablation is scheduled within the next 6 months.
- •age ≥18 years
- •Patient affiliated to a social security scheme
- •Patient informed and given written consent for participation in the study.
排除标准
- •Refusal to participate in the study
- •Patient who has already benefited from an AF ablation procedure
- •Patient for whom an AF ablation procedure by cryoablation system is planned
- •Scanner or MRI pre-inclusion not exploitable
- •Presence of an implantable cardiac prosthesis of pacemaker type or defibrillator
- •Claustrophobia
- •Iodinated / gadolinium contrast medium allergy
- •Chronic renal failure with clearance <30ml / min
- •Follow-up visits not possible
- •Pregnancy in progress
- •Patients unable to sign consent
- •Minors and adults protected under legal protection (tutorship or guardianship)
- •Period of exclusion from a research study
结局指标
主要结局
Prognostic value of automated measurement of epicardial fat in CT and and total left atrial strain in MRI
时间窗: At 1 year
Relationship between the relative volume of left atrial fat and total left atrial strain in MRI and recurrence of atrial rhythm disturbances (defined as sustained atrial rhythm disturbance\> 30 seconds) at 1 year after the ablation procedure (blanking period of 3 months post ablation excluded)
次要结局
- Correlation between the fat volume and the biomarkers.(At 1 year)
- Comparaison of prognostic value of automated measurement of epicardial fat in CT and the references methods(At 1 year)
- Comparaison of volume and distribution of left atrial fat and total strail strain with data from electrophysiological mapping(At 1 year)
- Longitudinal study of subepicardial fat volume assessed by CT after ablation(At 1 year)