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临床试验/NCT02882139
NCT02882139Unknown不适用

Multicenter Registry on Patients Affected by Electrical Storm

Università Politecnica delle Marche1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
All-cause mortality

研究概览

简要总结

Organized ventricular arrhythmias (ventricular tachycardia (VT), torsades de pointes (TdP) and ventricular fibrillation (VF)) represent a major event in the clinical history of a patient and they can lead to hemodynamic instability and sudden cardiac death (SCD). Recurrences of ventricular arrhythmias and electrical instability have exponentially increased in the last decades and a new clinical entity called "electrical storm" (ES) has emerged as major morbidity and mortality factor. The ES is defined as a cluster of 3 or more sustained ventricular arrhythmias within 24 hours, or a sustained ventricular tachycardia lasting 12 hours or more and that does not respond to treatments.

Most of the patients presenting ES are already implanted with an ICD. This is due to 3 factors: first, patients with ICD implant are at higher risk to develop ventricular arrhythmias for the cardiac disease that led to the ICD implant. Second, the device records and treats also asymptomatic or poor symptomatic arrhythmic episodes that otherwise would not be detected. Third, and more important, the device gives the possibility to survive to an arrhythmic episode, making it possible for the patient to experience an ES. The incidence of ES is debated in different studies and ranges from 10 to 60% in patients with ICD for secondary prevention and from 4 to 7% in patients with ICD for primary prevention.

The aim of the ELECTRA registry is twofold:

  1. To create an international registry on clinical features, optimal therapy, ablation strategy, prognosis and the effect of ICD programming on patients with ES.
  2. To use the data derived from the registry for a prospective, observational study on mortality and rehospitalization rate in patients with ES.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of ES (documentation of 3 or more episodes of sustained ventricular arrhythmia within 24h or documentation of sustained ventricular tachycardia lasted at least 12h).In order to fulfill this criterion, a patient with a previous episode of ES could also be enrolled during routine screening.
  • Written informed consent

排除标准

  • patient without ICD
  • Confirmed or suspected use of drugs or narcotics with known direct pro-arrhythmic effect
  • Inability to express an informed consent for the study

结局指标

主要结局

All-cause mortality

时间窗: Three years

次要结局

  • Hospitalization for all causes(Three years)

研究者

发起方
Università Politecnica delle Marche
申办方类型
Other
责任方
Principal Investigator
主要研究者

Federico Guerra

Dr.

Università Politecnica delle Marche

研究点 (1)

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