A Randomized, Double-blinded Comparison of Iopromide and Iodixanol in Renally Impaired Patients Undergoing Cardiac Catheterization
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 592
- 试验地点
- 19
- 主要终点
- Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline.
研究概览
简要总结
The investigators intend to find out which contrast agent has less kidney toxicity in renal impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI).
详细描述
In the diagnosis and treatment of coronary heart disease, patients should undergo cardiac angiography or percutaneous coronary intervention (PCI). In those procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with chronic renal insufficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older
- •Plan to undergo Cardiac Catheterization
- •Signed ICF
- •eGFR: 30~59 mL/min/1.73m2
排除标准
- •Pregnancy
- •Under dialysis
- •Conditions interfering with Cardiac Catheterization
- •Participation in other trials
- •Allergic to X-ray contrast media
- •Administration of any investigational drug within the previous 30 days
- •Intra-arterial or intravenous administration of iodinated contrast medium from 7 days before to 72 hours after the administration of study drug
- •Left ventricular ejection fraction (LVEF) less than 30% by ultrasound examination
- •Intake of any nephrotoxic medications 24 hours before or after the administration of study drug
研究组 & 干预措施
Iopromide
Drug: Ultravist 370 mgl/ml, injection of intra-artery during cardiac interventional operation
干预措施: Iopromide (Ultravist) (Drug)
Iodixanol
Drug: Visipaque 320 mgl/ml, injection of intra-artery
干预措施: Iodixanol (Visipaque) (Drug)
结局指标
主要结局
Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline.
时间窗: day 3 postreatment
次要结局
- Proportion of patients developing acute renal failure.(day 30 postreatment)
- Incidence of a postdose SCr increase ≧25%, a postdose SCr increase ≧1mg/dL, a postdose SCr increase ≧0.5mg/dL, a postdose eGFR decrease ≧25%(days 3)