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临床试验/NCT03210883
NCT03210883
已完成
不适用

Global Electrical Heterogeneity and Clinical Outcomes

Larisa Tereshchenko6 个研究点 分布在 1 个国家目标入组 3,471 人2017年7月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Heart Failure
发起方
Larisa Tereshchenko
入组人数
3471
试验地点
6
主要终点
Primary competing outcome: All-cause death without preceding sustained VT/VF with appropriate ICD therapy
状态
已完成
最后更新
4年前

概览

简要总结

This retrospective multicenter cohort will validate an independent association of electrocardiographic (ECG) global electrical heterogeneity (GEH) measures with sustained ventricular tachyarrhythmias and appropriate ICD therapies in systolic heart failure patients with primary prevention ICD, and will validate and re-calibrate GEH ECG risk score for prediction of sustained ventricular tachyarrhythmias and appropriate ICD therapies in systolic heart failure patients with primary prevention ICD.

注册库
clinicaltrials.gov
开始日期
2017年7月1日
结束日期
2021年7月5日
最后更新
4年前
研究类型
Observational
性别
All

研究者

发起方
Larisa Tereshchenko
责任方
Sponsor Investigator
主要研究者

Larisa Tereshchenko

Associate Professor of Medicine

Oregon Health and Science University

入排标准

入选标准

  • records of systolic heart failure patients with primary prevention ICDs/CRT-Ds implanted for routine clinical indications

排除标准

  • absent baseline pre-implant digital ECG;
  • missing data on clinical predictors and covariates;
  • missing ICD programming data (including number of intervals to detect \[NID\] or time to detect, number of detection zones, heart rate for each detection zone, and anti-tachycardia pacing \[ATP\] programming);
  • missing outcomes data.
  • records of patients with inherited channelopathies (e.g. long QT syndrome, Brugada syndrome), inherited cardiomyopathies (e.g. hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy), and congenital heart disease.

结局指标

主要结局

Primary competing outcome: All-cause death without preceding sustained VT/VF with appropriate ICD therapy

时间窗: up to 15 years

All-cause death without preceding sustained ventricular tachyarrhythmia with appropriate ICD therapy

Primary outcome: sustained VT/VF event with appropriate ICD therapy (either ATP or shock)

时间窗: up to 15 years

Sustained ventricular tachyarrhythmia event with appropriate ICD therapy (either antitachycardia pacing or shock)

次要结局

  • sustained polymorphic ventricular tachycardia / ventricular fibrillation(up to 15 years)
  • sustained monomorphic ventricular tachycardia(up to 15 years)

研究点 (6)

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