跳至主要内容
临床试验/NCT02175836
NCT02175836Unknown不适用

Arrhythmia Prediction Trial and Risk Stratification in Heart Failure Patients - Athens.

University of Athens1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2007年10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
Sudden Cardiac Death surrogates: 1.Clinical Ventricular Tachyarrhythmia, 2.ICD's appropriate activation, 3.Confirmed Sudden Cardiac Death

研究概览

简要总结

Patients with Ischaemic and Dilated Cardiomyopathy, face an increased risk for Arrhythmic Sudden Cardiac Death. The purpose of this study is to estimate the performance of Modern Non-Invasive Indices and the performance of Programmed Ventricular Stimulation in Sudden Cardiac Death Prediction.

详细描述

Sudden Cardiac Death (SCD) threatens survival of Coronary Artery Disease and Dilated Cardiomyopathy patients with Heart Failure. Discovering efficient SCD risk stratification markers is of high importance. In this study, heart failure patients will be risk stratified with indices from the Myocardial substrate (QRS, fragmented QRS, Late potentials, LVEF), indices from the Repolarization status (QT duration, QT rate corrected , QT dispersion, QT/RR, T wave Amplitude Variability, T wave alternans, QT Variability Index), indices from the Autonomic Nervous System function [ Heart Rate variability, Heart rate Turbulence, Deceleration Capacity (DC) , DC sign of fraction, Beat to Beat DC, Non linear indices of Heart Rate Dynamics], the Non sustained ventricular tachycardia and Ventricular extrasystolic activity and the Circadian Properties of Heart Rate observed during Ambulatory Monitoring. Furthermore Programmed Ventricular Stimulation will be used. High resolution 30 min ECG recordings will performed for further indices research and development. All the Arrhythmic Risk Stratifiers will be analysed and their performance for Sudden Cardiac Death Prediction and for Total Mortality will be estimated according the follow up.

研究设计

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

入排标准

年龄范围
20 Years 至 82 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Myocardial Infarction
  • Dilated Cardiomyopathy
  • Sinus rhythm

排除标准

  • Malignant diseases seriously affecting the survival
  • Conditions/diseases affecting the Autonomic Nervous System's function
  • Alcoholism
  • Psychiatric diseases
  • Addiction

结局指标

主要结局

Sudden Cardiac Death surrogates: 1.Clinical Ventricular Tachyarrhythmia, 2.ICD's appropriate activation, 3.Confirmed Sudden Cardiac Death

时间窗: 2007-2019 (12 years)

次要结局

  • Total Mortality(2007-2019 (12 years))

研究者

发起方
University of Athens
申办方类型
Other
责任方
Principal Investigator
主要研究者

PETROS ARSENOS

MD, PhD

University of Athens

研究点 (1)

Loading locations...

相似试验