Assessment of the Effect of Atorvastatin and N-acetyl Cysteine on Prevention of Contrast Induced Nephropathy in Patients Undergoing Coronary Angiography CIN
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Contrast induced nephropathy (CIN) incidence
研究概览
简要总结
Given the limited understanding of the impact of statin and N-acetyl cysteine use before angiography in preventing contrast-induced nephropathy (CIN), the objective of this study is to evaluate the effectiveness of atorvastatin in preventing CIN among patients undergoing coronary angiography.
详细描述
A multi armed randomized controlled clinical trial to be conducted from June 2023.According to inclusion and exclusion criteria, All patients presenting to the Cardiology department at Ain Shams University hospitals, will be assessed for eligibility. At least 120 patients subjected to elective CT coronary angiography who are at risk of developing contrast-induced renal failure will be enrolled. The participants will be assigned to Three groups (40 patients for each group):
- Three groups
- High-dose Atorvastatin group: 40 patients will receive 80 mg Atorvastatin before coronary angiography and will receive adequate hydration using (1ml/kg/hr)
- N-acetyl cysteine group: 40 patients will receive 200mg 3 times daily 2 days before coronary angiography and 2 days after and will receive adequate hydration using (1ml/kg/hr)
- Control group: 40 patients will receive adequate hydration using (1ml/kg/hr) The blood sample will be collected from all patients before the administration of contrast media and after 24 hours for assessment of the needed parameters.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing elective Coronary angiography who will receive coronary angiography contrast media.
- •Must have at least two consecutive serum creatinine measurements (Before and after Contrast exposure)
排除标准
- •Pregnant or lactating women
- •Patients with Serum creatinine conc of >2.1 mg/Dl
- •Patients undergoing emergency primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.
- •Prior exposure to contrast media within 7 days
- •Contraindication for a high-dose statin, N-acetyl Cysteine prescription
研究组 & 干预措施
N-acetyl cysteine group
40 patients will receive 200mg 3 times daily 2 days before coronary angiography and 2 days after and will receive adequate hydration using (1ml/kg/hr)
干预措施: N-acetyl cysteine (Drug)
High-dose Atorvastatin group
40 patients will receive 80 mg Atorvastatin before coronary angiography and will receive adequate hydration using (1ml/kg/hr)
干预措施: Atorvastatin 80mg (Drug)
Control group
40 patients will receive adequate hydration using (1ml/kg/hr)
干预措施: Atorvastatin 80mg (Drug)
Control group
40 patients will receive adequate hydration using (1ml/kg/hr)
干预措施: N-acetyl cysteine (Drug)
Control group
40 patients will receive adequate hydration using (1ml/kg/hr)
干预措施: Normal Saline (Other)
结局指标
主要结局
Contrast induced nephropathy (CIN) incidence
时间窗: 24-48 hours after PCI
Contrast-induced nephropathy was defined as an absolute increase of 0.5 mg/dL or a relative increase of \>25% in creatinine levels 24-48 hours after the procedure. Contrast-induced nephropathy was defined as an absolute increase of 0.5 mg/dL or a relative increase of \>25% in creatinine levels 24-48 hours after the procedure. Contrast-induced nephropathy was defined as an absolute increase of 0.5 mg/dL or a relative increase of \>25% in creatinine levels 24-48 hours after the procedure. Contrast-induced nephropathy was defined as an absolute increase of 0.5 mg/dL or a relative increase of \>25% in creatinine levels 24-48 hours after the procedure. Contrast-induced nephropathy was defined as an absolute increase of 0.5 mg/dL or a relative increase of \>25% in creatinine levels
次要结局
- Serum Creatinine (S.Cr) level(48 hours after PCI)
研究者
Sarah Sabry Hashem
Clinical Pharmacist
Ain Shams University