Clinical-Electrophysiological Risk Marker Trial Goettingen
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
- 否
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
Markus Zabel
Associate Professor, Head of Clinical Electrophysiology
University Medical Center Goettingen
