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临床试验/EUCTR2007-003263-52-DE
EUCTR2007-003263-52-DE进行中(未招募)不适用

Gadofosveset Trisodium (Vasovist®) zur kontrastverstärkten MR-Angiographie der supraaortalen Arterien und zur Darstellung der Gefäßwand in der primären Kontrastmittelpassage („first pass) und in der intravasalen Phase („steady state) bei 3.OT

niversity of Bonn0 个研究点目标入组 50 人开始时间: 2007年8月15日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
50

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - male and female patients aged 18- 75 years
  • - written, voluntary informed consent
  • - patients are able to unterstand the meaning and consequences of the clinical trial
  • - Indication MRT, MRA/DSA to represent the supraaortale vessels
  • - GFR > or equal 60 ml/min (Cockroft Gault)
  • - TSH normal range
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - MRT is not possible (e.g. cardiac pacemacer, cochlea implant etc.)
  • - known or suspected pregnancy
  • - breastfeeding women
  • - Recent intracerebrale bleeding with suspected aneurysm or AV-malformation (has to be ruled out by CT, native)
  • - Known anaphylactic or anaphylactoid reaction in history
  • - life-threatening or haemodynamic instability
  • - inadequate renal function
  • - thyroid overactivity or hypothyreoidism
  • - seizure disorder
  • - untreated hypocaliaemia
  • - Known history of HIV infection or chronic hepatitis B or C infection
  • - participation in any other clinical trial within the last 3 months
  • - alcohol and/or substance abuse
  • - patients, who need an emergency therapy/current therapeutic intervention in the area that is to be tested within 24 hours following the initial diagnostics

研究者

发起方
niversity of Bonn

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