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
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