跳至主要内容
临床试验/NCT03079414
NCT03079414已完成不适用

The Role of Electrophysiology Testing in Survivors of Unexplained Cardiac Arrest

Western University, Canada21 个研究点 分布在 3 个国家目标入组 100 人开始时间: 2017年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
21
主要终点
Arrhythmic culprit for aborted cardiac arrest

研究概览

简要总结

Sudden cardiac death (SCD) remains a major cause of mortality within developed nations despite aggressive efforts to reduce its societal burden. Despite extensive clinical and genetic investigations, a subgroup of cardiac arrests remain unexplained, highlighting the potential contribution of additional cardiac conditions that may not be identified with contemporary diagnostic algorithms. The EPS ARREST study aims to evaluate the role of invasive electrophysiology study within this patient population.

详细描述

The majority of cases of SCD in older individuals occur secondary to coronary and structural heart disease, while genetic channelopathies and cardiomyopathies are prominent contributors in young adults. Among individuals that suffer aborted cardiac arrests in the absence of overt coronary and structural heart disease, diagnostic algorithms that screen for cardiac channelopathies and more subtle forms of structural heart disease have been established. Despite the extensive investigations currently utilized, a significant proportion of aborted cardiac arrests remain unexplained.

Although invasive electrophysiology studies are a cornerstone for diagnosis and management of arrhythmia disorders, they are not invariably included in the workup of cases of unexplained aborted cardiac arrest. This is largely driven by initial studies suggesting that the diagnostic yield in this context is low, however these investigations often used invasive electrophysiology studies indiscriminately in all cases of aborted cardiac arrest. Since these earlier studies, our insight and approach to SCD has evolved and it has become clear that the majority of patients do not require an invasive electrophysiology study for diagnosis. However an invasive electrophysiology study may still have an important role among these individuals when the initial workup is negative. Notably, arrhythmias that require invasive electrophysiology for diagnosis, including bundle branch reentrant ventricular tachycardia and supraventricular tachycardias associated with hemodynamic collapse, have been identified as arrhythmic culprits in this patient population.

The goal of the EPS ARREST study is to evaluate the diagnostic yield of a standardized invasive electrophysiology study among survivors of SCD when initial investigations fail to identify an underlying etiology.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Unexplained cardiac arrest requiring cardioversion or defibrillation
  • Willing and able to sign informed consent

排除标准

  • Coronary artery disease (stenosis > 50%) and clinical findings consistent with an ischemic arrest
  • Reduced left ventricular function (left ventricular ejection fraction < 50%) on echocardiogram or cardiac MRI.
  • Persistent resting QTc > 460 msec for males and 480 msec for females
  • Resting QTc < 350 msec
  • Type I Brugada ECG with >/= 2 mm ST elevation in V1 and/or V2 (Spontaneous or Drug-Induced)
  • Polymorphic or bidirectional ventricular tachycardia observed with exertion on exercise treadmill testing
  • Clinical, electrocardiographic, and/or imaging findings consistent with a diagnosis of arrhythmogenic right ventricular cardiomyopathy
  • Myocarditis
  • Reversible cause of cardiac arrest such as marked hypokalemia (<2.8 mmol/l) or drug overdose sufficient in severity without other cause to explain the cardiac arrest.
  • Arrhythmic mitral valve prolapse syndrome
  • Documented ventricular fibrillation initiated by a short-coupled premature ventricular contraction

结局指标

主要结局

Arrhythmic culprit for aborted cardiac arrest

时间窗: Assessed immediately upon testing

Identification of an arrhythmic culprit for aborted cardiac arrest using an invasive electrophysiology study.

次要结局

  • Prevalence of supraventricular tachycardia associated with hemodynamic collapse(Assessed immediately upon testing)
  • Prevalence of bundle branch reentrant ventricular tachycardia(Assessed immediately upon testing)
  • Prevalence of a latent/cryptic accessory pathway(Assessed immediately upon testing.)

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Sponsor

研究点 (21)

Loading locations...

相似试验

The Role of Electrophysiology Testing in Survivors... | 临床试验