Relationship Between the Gene Polymorphism of Aldehyde Dehydrogenase 2 and Contrast Induced Nephropathy
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change from baseline renal function after the operation
研究概览
简要总结
The purpose of this clinical trial is to investigate the relationship between the gene polymorphism of aldehyde dehydrogenase 2 and contrast induced nephropathy and its mechanism.
详细描述
Patients undergoing coronary angiography or percutaneous coronary intervention will be recruited in this study after they sign the informed consent.5ml venous blood was extracted from the peripheral vein before the operation to detect the renal function, the genotype and enzyme activity of aldehyde dehydrogenase 2 ,and the levels of oxidative stress and inflammation.Another 5ml venous blood was extracted from the peripheral vein 24-72 hours after the operation to detect the renal function and the levels of oxidative stress and inflammation.Activated oxygen protein products , 4-HNE and hs-CRP as markers for oxidative stress and inflammation.The renal function index contains serum creatinine，urea nitrogen and cystatin C.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patients undergoing elective coronary intervention or coronary angiography at Yu Qilu hospital.
- •All the patients or their guardians must sign the consent form before entering the trial.
排除标准
- •Patients with acute renal failure, renal transplantation, end-stage renal disease, or dialysis treatment, GFR < 15ml/min.
- •Use of renal toxicity drugs during the treatment, such as non steroidal anti-inflammatory drugs, etc.
- •Patients who has used contrast agent 10 days before the operation.
- •Cardiac shock, hypotension (systolic blood pressure < 95mmHg),or hyper- tension with difficulty to control.
- •Allergy to contrast media.
- •Congestive heart failure (left ventricular ejection fraction<40%), cardiac function NYHA grade IV.
- •Pregnancy or lactation.
结局指标
主要结局
Change from baseline renal function after the operation
时间窗: at admission and 24-72hours after coronary angiography or coronary intervention
The baseline of renal function will be tested at the next morning after admission .The renal function will be tested again 24-72 hours after coronary angiography or coronary intervention.The changes of renal function will be recorded.The renal function index contains serum creatinine,urea nitrogen and cystatin C.
Number of patients with different ALDH2 genotype
时间窗: 1-30 days after samples collected
次要结局
- Activated oxygen protein products, 4-HNE and hs-CRP(1-30 days after samples collected)
- Aldehyde dehydrogenase 2 activity(1-30 days after samples collected)