Better Mechanistic Understanding of and Risk Stratification for Ventricular Tachyarrhythmias Through ECGI
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 270
- 试验地点
- 4
- 主要终点
- ECG-Imaging outcome: epicardial potentials
研究概览
简要总结
This study aims to evaluate the electrophysiological properties of the heart conduction system in patients with (increased risk of) ventricular tachyarrhythmias (VTA) and sudden cardiac arrest, and in a control cohort. The electrophysiological properties will be measured with the relatively new technique ECG-Imaging (ECGI). Moreover, clinical data of subjects will be gathered.
By combining the data from the data gathering and the results of ECGI, the investigators hope to increase mechanistic understanding of and risk stratification for VTAs. The investigators aim to be able to identify patients at risk of an arrhythmic event, and aim for better treatment strategies in the future.
详细描述
ECGI combines electrical body-surface mapping with 256 electrodes placed on the thorax with a CT-scan obtaining the anatomy of the heart and torso, hereby able to reconstruct local electrograms, activation and recovery times. In recent research, ECGI provided numerous extra insights into normal cardiac electrophysiology, but also electrophysiological disorders and disease. The results strongly suggest that ECGI can play a pivotal role in further characterizing arrhythmia mechanisms, therefore could do so for VTAs, leading to diagnosis and treatment improvement. Moreover, ECGI seems to have the potential to detect arrhythmogenic substrate in individuals before their first event, offering the possibility to diagnose and treat patients before sudden cardiac arrest occurs.
In the BREACH-ECGI study:
ECGI will be used to noninvasively characterize the epicardial electrophysiological substrate and triggers of:
- Patients with (increased risk of) VTAs
- A control cohort. Results will be evaluated for increased mechanistic understanding and risk stratification.
Moreover, clinical data of subjects will be gathered. These data will be analyzed to determine their prognostic value in terms of arrhythmia risk
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Care Provider)
盲法说明
The treating physician is not informed about the results of the procedure.
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
- •In order to be eligible to participate in this study, a subject must be ≥ 18 years old, have either a history of VTAs or be at risk of VTAs and have one of the following diagnoses:
- •Ischemic cardiomyopathy
- •Non-ischemic cardiomyopathy
- •Non-structural heart disease
- •Congenital heart disease (with a limitation to CCTGA and situs inversus)
- •Or: a subject must be ≥ 18 years old and have a structurally normal heart with a clinical indication for a cardiac CT.
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •A known strong reaction against electrode attachment or contrast agent.
- •Any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study.
- •Pregnancy, nursing or planning to be pregnant.
- •The subject has an estimated glomerular filtration rate (eGFR) of <30mL/min/1.73m2, using the MDRD calculation
- •Being unable to give informed consent.
结局指标
主要结局
ECG-Imaging outcome: epicardial potentials
时间窗: 3 years
reconstructed epicardial potentials, represented in mV over time(s).
ECG-Imaging outcome: activation and repolarization maps
时间窗: 3 years
Activation and repolarization maps. Acivation and repolarization times are determined from the epicardial potentials, expressed in ms. These are shown on a CT-derived or CMR-derived heart mesh. The entire activation and repolarization of the epicardium of the heart can be visualized this way.
次要结局
- (Possible) Prognostic risk factors for recurrent ventricular arrhythmias(6 years)
- Recurrence of ventricular arrhythmias(6 years)