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临床试验/NCT02010515
NCT02010515已完成不适用

Clinical-Electrophysiological Risk Marker Trial Goettingen

University Medical Center Goettingen1 个研究点 分布在 1 个国家目标入组 282 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
282
试验地点
1
主要终点
All-Cause Mortality

研究概览

简要总结

This prospective single-center study is an observational risk stratification trial in about 250 patients with standard indications for ICD treatment.

Implantable cardioverter defibrillators (ICD) have been shown to improve survival and current guidelines recommend their use for primary and secondary prevention of sudden cardiac death (SCD). However, a large number of patients never receive an appropriate therapy from their device. In contrast, electrical sorm and multiple ICD shocks occur in other patients.

Thus, identification of predictors for survival or ICD shocks is necessary for improved patient selection and optimized therapeutic strategies.

Risk stratification with electrocardiogram (ECG) and signal averaged ECG (SAECG), T-wave alternans (TWA) and Holter ECG including premature ventricular contractions (PVC), non-sustained VT (nsVT), heart rate variability (HRV), heart rate turbulence (HRT) and deceleration capacity, as well as clinical variables is possible, but not implemented in clinical routine in patients with ischemic or dilated cardiomyopathy and newly implanted ICD for primary or secondary prevention of SCD following current guidelines.

Patients will be prospectively followed and the predictive value of the risk markers mentioned above to predict all-cause mortality or appropriate ICD shocks will be investigated.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • ischemic or dilated cardiomyopathy
  • sinusrhythm
  • ICD indication strictly following current guidelines (primary and secondary prevention of SCD)
  • Age 18 years or older

排除标准

  • no consent
  • atrial fibrillation

结局指标

主要结局

All-Cause Mortality

时间窗: 2008-2013

First Appropriate ICD Shock

时间窗: 2008-2013

First ICD discharge for malignant ventricular arrhythmia

次要结局

未报告次要终点

研究者

发起方
University Medical Center Goettingen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Markus Zabel

Associate Professor, Head of Clinical Electrophysiology

University Medical Center Goettingen

研究点 (1)

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