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临床试验/NL-OMON52499
NL-OMON52499招募中不适用

Better mechanistic understanding and risk stratification of ventricular arrhythmias through ECGI - BREACH-ECGI

Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 270 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
270

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • In order to be eligible to participate in this study, a subject must be >= 18
  • years old, have a either a history or a risk of VTAs and have one of the
  • following diagnoses:
  • - Ischemic cardiomyopathy
  • - Non-ischemic cardiomyopathy
  • - Non-structural heart disease
  • - Congenital heart disease (with a limitation to CCTGA and situs inversus)
  • Or: a subject must be >= 18 years old and have a structurally normal heart.

排除标准

  • A potential subject who meets any of the following criteria will be excluded
  • from participation in this study:,
  • A known strong reaction against electrode attachment.
  • Any serious medical condition, which in the opinion of the investigator, may
  • adversely affect the safety and/or effectiveness of the participant or the
  • Pregnancy, nursing or planning to be pregnant.
  • In case of a CT scan: the subject has an estimated glomerular filtration rate
  • (eGFR) of <30mL/min/1.73m2, using the MDRD calculation 14.
  • In case of a CT scan: A known strong reaction against contrast agent.
  • In case of an MRI scan: the subject is unsuitable to get an MRI scan (such as
  • described in ODIN protocols *Voorbereiding klinische patiënten voor MRI
  • onderzoek* and *Uitvoering van MRI onderzoek bij patiënten met een cardiaal
  • implanteerbare elektronisch device, waaronder een pacemaker en ICD*):
  • o Non-MRI-compatible metallic implants (vascular clip, neuro-stimulator,
  • cochlear implant etc.).
  • o Non-MRI-compatible pacemaker or implantable cardiac defibrillator (ICD).
  • o Claustrophobia.
  • Being unable to give informed consent.

研究者

发起方
Medisch Universitair Ziekenhuis Maastricht

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