The Effect of Continuing or Discontinuing ACE-I/ARBs Therapy on the Incidence of Contrast-induced Nephropathy in Patients With Chronic Kidney Disease Undergoing Coronary Angiography; a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Number of Participants with Contrast induced nephropathy
研究概览
简要总结
Contrast induced nephropathy (CIN) is a well-known possible complication of percutaneous coronary intervention (PCI) with an incidence varies from 3.3% to 14.5% in patients undergoing PCI.
Many previous randomized and non-randomized studies have shown very conflicting results regarding the use of ACE-Is prior to coronary angiography, and whether it decreases or increases the risk of CIN. The importance of this study is to help find an acceptable and reliable answer for the use of ACE-I/ARBs prior to cardiac catheterization.
This research aims to study the effect of withholding ACE-Is or ARBs on the incidence of contrast induced nephropathy in patients undergoing coronary angiography who have chronic kidney disease (GFR<60 ml/min/1.73 m2) and to help build evidence-based data and guidelines on the safety of continuing or withholding ACE-I/ARBs pre contrast administration.
详细描述
The study design is a Randomized Control Trial; it will be done on two groups of patients. The two groups are group A (continue ACE-I/ARBs) and group B (withhold ACE-I/ARBs).
The study will be conducted at the cardiology units at An-Najah National University's hospital (NNUH) in Nablus, Palestine.
Study population includes chronic kidney disease patients taking ACE-I or ARBs therapy and are undergoing elective coronary angiography.
Patients who will meet the inclusion criteria and have none of the exclusion criteria will be enrolled in the trial when the appointment of their procedure is set.
They will be randomly divided into two groups; group A (continue ACE-I or ARBs therapy) and group B (withhold ACE-I or ARBs therapy)using block randomization, each block consists of four participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Patients enrolled to the study were randomized into continuing or discontinuing (ACEI/ARBs) group. Care providers and investigators collected their data before and after the coronary angiography. The independent variable - continuing or discontinuing (ACEI/ARBs) - was coded into A or B groups, then data was sent to the outcomes assessor.
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
- •At least one month of continuous therapy with an ACEI or an ARBs and
- •Undergoing elective coronary angiography and
- •Have CKD stage3-4 (15≤GFR<60 ml/min/1.73 m2).
排除标准
- •Acute STEMI within 2 weeks
- •NYHA class IV heart failure by history
- •Administration of contrast load within the previous 6 days
- •acute renal failure (ARF) preceding coronary angiography
- •potassium level more than 5.0 meq/l
- •GFR <15 ml/min/1.73 m2
- •previous percutaneous cardiac catheterization within one month
- •Acute pulmonary edema
- •hemodynamically instability
- •uncontrolled hypertension
- •combination ACEI and ARB therapy
- •Cardiogenic shock
- •Age below 18 year
结局指标
主要结局
Number of Participants with Contrast induced nephropathy
时间窗: 48 - 72 hours post-cardiac catheterization
Contrast induced nephropathy (creatinine rise of ≥0.5 mg/dL or a relative increase ≥25%compared to the pre-randomization creatinine level) at 48-72hrs
次要结局
- Serum creatinine level(48 - 72 hours post-cardiac catheterization)
- Creatinine clearance(48 - 72 hours post-cardiac catheterization)
- Death, Myocardial Infarction, Stroke, Congestive Heart Failure, dialysis, major bleeding, minor bleeding, hypertension, re-hospitalization at 48-72hrs(48 - 72 hours post-cardiac catheterization)
- Number of Participants with Hyperkalemia(48 - 72 hours post-cardiac catheterization)
研究者
Yunis Daralammouri
Assistant Professor
An-Najah National University