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临床试验/NCT03475498
NCT03475498招募中不适用

A Major Determinant Focused on the ECG or Echocardiogram for Pacing-induced Cardiomyopathy (PICM) and Its Clinical Outcome (PICM Syndrome) : Prospective, Multi-center, Observational Cohort Study.

Eulji University Hospital3 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2018年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
3
主要终点
Heart failure diagnosis and treatment

研究概览

简要总结

Chronic right ventricular pacing has a deleterious effect on left ventricular (LV) function, namely pacing-induced cardiomyopathy (PICM). Several parametes make difference of effect on the occurrence of PICM and its subsequent clinical outcomes. In particular, recognition of a major determinant focused on the ECG or echocardiographic parameters including strain or genetic factor for occurrence of PICM may lead to better identification of patients at high risk. Investigators prospectively enroll a participant with documented high risk of PICM and clinically follow-up to idenify clinical impact of PICM (PICM syndrome) over a long period of time.

详细描述

Investigators investigate a major determinant focused on the ECG or echocardiogram or genetic factor to predict the PICM after implantation of pacemaker. Not only QRS duration and mechanical strain but also genetic factor could be also investigated to predict the occurrence of PICM before diagnosis fo PICM

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • mandatory (1 and 2) and optional (3 or 4)
  • Willng to participate in the study and able to sign informed consent
  • Undertaken ECG and echocardiogram including strain before and after device implantation

排除标准

  • Less than 18 years of age
  • Being pregnant or plan to become pregnant
  • Advanced heart failure waiting in heart transplantation
  • Have a life expectancy of less than 1 year

结局指标

主要结局

Heart failure diagnosis and treatment

时间窗: 5 years

Occurrence of heart failure symptom, diagnosis and treatment

次要结局

  • Atrial and Ventricular arrhythmia diagnosis, heart failure admisssion and all-caused mortality(5 years)

研究者

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

Ki-Woon Kang, MD

Professor

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

研究点 (3)

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