The Contrast Media and Nephrotoxicity Following Coronary Revascularization by Primary Angioplasty for Acute Myocardial Infarction. The CONTRAST-AMI Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 432
- 试验地点
- 1
- 主要终点
- Incidence of Contrast Induced Nephropathy (CIN) between the two study groups, defined as relative increase of serum Creatinine of 25% or more from basal values
研究概览
简要总结
The purpose of this study is to determine the incidence of contrast induced nephropathy and myocardial tissue reperfusion following iso-osmolar iodixanol or ipo-osmolar iopromide administration in patients with acute myocardial infarction undergoing primary PCI.
详细描述
This is a multicentric randomized comparison between iso-osmolar and ipo-osmolar contrast agents in patients treated with primary PCI with the evaluation of contrast-induced nephropathy incidence and myocardial tissue reperfusion. The study was designed as a non-inferiority trial.
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
- Double (Participant, Investigator)
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
- •Men or women aged ≥ 18
- •Patients with ST-elevation Myocardial Infarction presenting within 12 hours after the onset of symptoms (18 hours in case of cardiogenic shock), who are scheduled to undergo primary PCI
- •Patients who have signed and dated the written informed consent form
排除标准
- •Patients in pregnancy or lactation
- •Long-term dialysis
- •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
- •Intake of any nephrotoxic medications 24 hours before or after the administration of study drug
- •Contraindications to the study drug or the cardiac catheterization procedure
- •Previous participation in this study
- •As the discretion of the investigator, the patient has any conditions not appropriate to the usage of iodinated contrast agent or not appropriate to undergo cardiac catheterization procedure
研究组 & 干预措施
iodixanol
Iso-osmolar contrast medium (Iodixanol) will be administered during PCI
干预措施: Iodixanol (Drug)
iopromide
Low-osmolar contrast medium (Iopromide) will be administered during PCI
干预措施: Iopromide (Drug)
结局指标
主要结局
Incidence of Contrast Induced Nephropathy (CIN) between the two study groups, defined as relative increase of serum Creatinine of 25% or more from basal values
时间窗: days 1, 2, 3, and at discharge
次要结局
- TIMI grade flow(before and after primary PCI)
- Corrected TFC (TIMI frame count)(after primary PCI)
- TMPG (TIMI Myocardial Perfusion Grade)(after PCI)
- LFR slope (load to function slope)(after primary PCI)
- MACE(1, 6, 12 months)
- absolute increase in serum Creatinine(days 1, 2, 3, and at discharge)
- relative increase in serum creatinine of 50% or more(days 1, 2, 3, and at discharge)