跳至主要内容
临床试验/NCT02415348
NCT02415348Unknown不适用

The Use of Fibroscan to Assess Liver Fibrosis in Patients With Cardiac Pacemakers and/or Implantable Cardioverter-Defibrillators

University of Saskatchewan2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
2
主要终点
Rate of Pacemaker/ICD malfunction

研究概览

简要总结

This study is designed to determine if the Fibroscan (Echosens, Paris), a non-invasive, ultrasound-based device used to estimate fibrosis in patients with chronic liver disease, interferes with implanted cardiac pacemaker and/or implantable cardioverter-defibrillators. Recruitment consists of a total of 200 outpatients undergoing routine pacemaker interrogation at a teaching-hospital pacemaker clinic.

详细描述

Assessment of liver fibrosis in patients with chronic liver diseases provides staging and prognostic information critical in establishing treatment priorities. The gold standard evaluation of liver fibrosis is hampered by the invasive nature of liver biopsies. FibroScan is a non-invasive alternative that has been extensively validated in chronic hepatitis C, chronic hepatitis B, alcoholic liver disease, and non- alcoholic fatty liver disease patients.

To avoid unknown risks of potential interaction, the manufacturer have advised against the use of the device in patients with active implantable medical device including cardiac pacemaker and/or implantable cardioverter-defibrillators(ICD). Review of the literature showed that these two population have been specifically excluded in all previously reported studies.

At the time of writing, no specific reports have demonstrated either safety or potential harm of the FibroScan in patients with pacemaker/ICD. Given the proven benefit of the FibroScan in chronic liver disease and the current policy of excluding patients with pacemaker/ICD in clinical practice, this study aims to formally evaluate the safe use of the FibroScan in this population within the controlled environment of a pacemaker lab.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any outpatient undergoing routine pacemaker interrogation at pacemaker clinic

排除标准

  • Pregnancy
  • Person with active implantable medical devices other than cardiac pacemaker and/or ICD
  • Person who are unable to tolerate lying flat for the FibroScan examination.

结局指标

主要结局

Rate of Pacemaker/ICD malfunction

时间窗: 30 min

Type of Pacemaker/ICD malfunction

时间窗: 30 min

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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