跳至主要内容
临床试验/NCT00356239
NCT00356239Unknown不适用

Evaluation of Safety and Feasibility Magnetic Resonance Imaging of the Heart at 1.5 Tesla In Patients With Implantable Cardioverter Defibrillators

University Hospital, Bonn1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2006年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
25
试验地点
1

研究概览

简要总结

To evaluate short-term and long-term effects by MR imaging on the technical and functional status of implantable cardioverter defibrillators.

详细描述

The presence of an implantable cardioverter defibrillators (ICD) is currently considered an absolute contraindication to MR imaging, and most patients with PM are excluded from having MRI. As a result from studies such as MADIT I, MADIT II, SCDHeft etc. the number of patients with ICDs has been continuously growing over the past years, ans this development will continue.

The aim of this study is to develop a strategy for safe performance of MR imaging at 1.5T, which included restriction of specific absorption rate (SAR) values to minimize the risk of lead heating, and ICD reprogramming to avoid interference from time varying gradient fields. The safety of this approach is then evaluated in a large group of ICD patients including assessment of potential myocardial thermal injury by measuring serum troponin I and pacing capture thresholds, and performing a follow-up 6 weeks after MR imaging to evaluate long-term effects.

研究设计

研究类型
Observational
观察模型
Defined Population
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Implantable Cardioverter Defibrillator
  • congestive heart failure
  • informed consent

排除标准

  • Non-MRI-compatible implants

研究者

发起方
University Hospital, Bonn
申办方类型
Other

研究点 (1)

Loading locations...

相似试验