NCT02070679已完成3 期
Efficacy of Vitamin E in Preventing Contrast-Induced Acute Kidney Injury Following Coronary Angiography
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 2
- 主要终点
- The development of CI-AKI in group receiving vitamin E compared with placebo
研究概览
简要总结
The purpose of this study is to evaluate the effect of vitamin E on preventing from incidence of contrast induced acute kidney injury (CI-AKI) in the patients who undergone coronary angiography.
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
- Triple (Participant, Care Provider, 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
- •All patients whon have either stable coronary artery disease (CAD) or recent acute coronary disease (ACS) and are scheduled for coronary angiography.
- •Patients who have eGFR ≤60 ml/min/1.73 m2
排除标准
- •Allergy to contrast media
- •Cardiogenic shock
- •Pulmonary edema
- •Overt cardiac failure or left ventricular ejection fraction ≤ 30%
- •Acute kidney injury
- •The history of receiving contrast media for any medical diagnostic or therapeutic procedures during previous 5 days
- •The history of dialysis
- •Being pregnant
- •Having recent acute myocardial infarction
- •Taking antioxidants and nephrotoxic drugs including NSAID and ACE-I on previous 2 days
研究组 & 干预措施
Vit-E
Active Comparator
600 IU on 12 hours before angiography and 400 IU on 2 hours before angiography
干预措施: Vitamin E (Drug)
结局指标
主要结局
The development of CI-AKI in group receiving vitamin E compared with placebo
时间窗: Within 72 hours after coronary angiography
次要结局
- Changes in the serum level of Cr and the amount of eGFR(Within 72 hours)
研究者
Chancellor of research
Mir Hossein Seyyed-Mohammadzad
Urmia University of Medical Sciences
研究点 (2)
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