Clinical Study Evaluating the Effect of Continuing or Discontinuing Angiotensin-Converting Enzyme Inhibitor on Renal Function in Patients Undergoing Coronary Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change From Baseline in Serum Creatinine at 72 Hours Post-Angiography
研究概览
简要总结
This clinical trial evaluates whether continuing or withholding ACE inhibitors (specifically Ramipril) before coronary angiography affects the risk of contrast-induced nephropathy (CIN). CIN is a known complication of iodinated contrast exposure, particularly in patients with chronic conditions such as hypertension or diabetes. The trial involves 44 adult patients randomized into two groups: one continuing Ramipril and the other withholding it 48 hours before and restarting 72 hours after the procedure. Renal biomarkers including serum creatinine, NGAL, and superoxide dismutase will be assessed to evaluate renal function.
详细描述
This randomized controlled study is designed to provide clinical evidence on whether withholding ACE inhibitors prior to contrast administration in coronary angiography affects kidney function. Participants are randomized into two arms: one arm will discontinue ACE inhibitors 48 hours prior and restart 72 hours post angiography, while the other will continue therapy without interruption. Primary endpoints include incidence of CIN as defined by a ≥0.5 mg/dL or ≥25% increase in serum creatinine within 72 hours. Secondary endpoints include NGAL, SOD, and potassium levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years) scheduled for elective coronary angiography
- •Currently on ACE inhibitor (Ramipril)
- •Serum creatinine ≤1.5 mg/dL
排除标准
- •STEMI within last 2 weeks
- •NYHA Class IV heart failure
- •CrCl <50 mL/min
- •Serum potassium >5.0 mEq/L
- •Recent contrast exposure
- •Pregnancy or breastfeeding
- •Cardiogenic shock or sepsis
- •Severe uncontrolled hypertension
研究组 & 干预措施
Arm 1: Withholding Ramipril
Discontinue Ramipril 48 hours prior to coronary angiograph.
干预措施: Withholding Ramipril (Drug)
Arm 2: Continuing Ramipril
Continue Ramipril throughout the peri-procedural period.
干预措施: Continuing Ramipril (Drug)
结局指标
主要结局
Change From Baseline in Serum Creatinine at 72 Hours Post-Angiography
时间窗: Baseline and 72 hours post-angiography
CIN defined as ≥0.5 mg/dL or ≥25% rise in serum creatinine from baseline.
次要结局
- Change in NGAL and SOD levels (pre vs post)(Baseline and 72 hours post-angiography)
- Incidence of Hyperkalemia After Coronary Angiography(Within 72 hours post-angiography)
- Incidence of Clinical Adverse Events Within 72 Hours(Within 72 hours post-angiography)
研究者
Ahmed Magdy Ali Mohamed Radwan
Dr
Tanta University