EUCTR2005-003832-24-DE进行中（未招募）不适用
An open, prospective, randomized, comparative study to evaluate the effect of Iodixanol 320 compared to Iomeprol 350 on contrast medium induced nephropathy in patients with impaired renal function undergoing percutaneous coronary intervention - CONTRAST
Deutsches Herzzentrum München0 个研究点目标入组 900 人开始时间: 2006年4月18日最近更新:
适应症
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
- 900
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
- •-Patients with a clinical indication for performing a diagnostic and/or interventional heart catheterization including a coronary angiography.
- •-Presence of chronic renal failure as defined by impaired glomerular filtration rate (GFR;<60ml/min) as assessed by the MDRD formula
- •-Written informed consent
- •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
- •-Age <18 years
- •-Cardiogenic shock
- •-Prior kidney transplantation
- •-Concurrent intake of nephrotoxic medication (e.g., non-steroidal antiphlogistics, aminoglycosides)
- •-Contra-indications for the use of iodixanol and iomeprol
- •-Parenteral (i.v. or i.a.) administration of iodine-containing contrast medium either 7 days before or after the catheter intervention
- •-Presumed or demonstrated pregnancy
- •-Patient's inability to fully cooperate with the study protocol
- •-Prior participation to this study
研究者
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