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临床试验/NCT05099783
NCT05099783Unknown不适用

Stepwise Strategy for Modifying Atrial Fibrillation Substrate Study - Regression of Left Atrial Fibrosis Assessed by Late Gadolinium Enhanced Magnetic Resonance Imaging

The Second Affiliated Hospital of Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
The regression of left atrial fibrosis in patients with persist atrial fibrillation after cardioversion

研究概览

简要总结

The investigators will conduct an observational trial, with outcome ascertainment at 3 months and 6 months after cardioversion. The primary objective is to demonstrate how cardioversion may aid in the regression of left atrial fibrosis in patients with persist atrial fibrillation as assessed by late gadolinium enhanced magnetic resonance imaging. The secondary objective is to assess the relationship between structural and functional changes with heart rhythm and heart rate.

详细描述

Background: Atrial fibrillation (AF) is estimated to affect over 33 million people worldwide and is associated with significant co-morbidities such as embolic stroke, heart failure, dementia. Consequently, AF poses a significant burden to the healthcare system, in both direct and indirect costs. The management of AF is complex, especially for patients with persistent AF, which is defined as sustained AF for > 7 days. It is preferable to terminate the AF and restore normal sinus rhythm for relief of symptoms associated with AF or improvement of cardiac structure and function. The maintenance of AF, especially persist AF is associated with fibrosis of left atria. Furthermore, AF itself promotes fibrosis, which in turn leads to increased conduction heterogeneity within the atrial substrate resulting in further progression of AF. In animal models, alterations in myocytes after sustained AF resemble those of myocardial hibernation. Ultimately, these structural changes would lead to Calcium overload and metabolic stress, similar changes have been observed in humans. In humans, atrial dilatation and degenerative changes have been observed. Interstitial fibrosis is the prime cause of structural remodeling in left atrium. Whether reversal of sinus rhythm can reverse fibrosis partly? The introduction of Late Gadolinium enhancement magnetic resonance imaging (LGE-MRI) sequence now allows for non-invasive and dynamic assessment of the location and extent of atrial fibrosis.

To date, no studies evaluating the regression of left atrial fibrosis after cardioversion assessed by LGE-MRI have been performed. The investigators propose to use LGE-MRI to evaluate the effects of cardioversion on atrial fibrosis. It has been shown that the extent of fibrosis can predict the success of catheter ablation procedure. For these patients with more "scar", control the progression of fibrosis and simultaneously provide respite from AF recurrence would be an extremely desirable prescription.

Objectives: To determine the regression of left atrial fibrosis in patients with persist atrial fibrillation as assessed by late gadolinium enhanced magnetic resonance imaging.

Methods: This study will be an observational trial in patients with persist AF. Candidate inpatients or outpatients will be identified if MRI were performed after pharmacological or electrical cardioversion at least twice. The heart rhythm will be assessed by medical records and telephone survey.

Objective

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients carry a diagnosis of Persistent Atrial Fibrillation
  • Patients have given informed consent
  • Pharmacological or electrical cardioversion has be performed successfully
  • late gadolinium enhanced magnetic resonance imaging (LGE-MRI) were performed after cardioversion at least twice

排除标准

  • Prior radiofrequency ablation treatment for atrial fibrillation
  • Prior cardiac surgical procedures
  • Individuals with cognitive impairments who are unable to give informed consent

结局指标

主要结局

The regression of left atrial fibrosis in patients with persist atrial fibrillation after cardioversion

时间窗: 3 to 6 months

The change in left atrial fibrosis (the core and border zone area, percentage of left atrium and segments involved) using MRI imaging, from baseline to the second measurement.

次要结局

  • The effects of sinus rhythm in global parameters of myocardial remodeling(3 to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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