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.
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. Patients in the continuation group will take their regular ACE-I/ARBs on the day of the angiogram. Patients in the discontinuation group will be withheld from their ACEI or ARBs 24 h before cardiac catheterization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
600
Randomized to continue on prescribed ACE1 or ARBs ( Enalapril 5, 10, 20 mg // Ramipril 2.5 , 5 mg // Valsartan 80 , 160 mg // Candesartan 8, 16 mg // Losartan 50 mg )
Angiotensin converting enzyme inhibitor or angiotensin receptor blocker held at least 24 hours pre-cardiac catheterization and restarted 48-72 hours post-catheterization (after creatinine measurement) Other Name: Includes all ACEI inhibitors or ARBs
An-Najah National University Hospital
Nablus, West Bank, Palestinian Territories
RECRUITINGNumber of Participants with Contrast induced nephropathy
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
Time frame: 48 - 72 hours post-cardiac catheterization
Serum creatinine level
Change in serum creatinine at 48-72hrs
Time frame: 48 - 72 hours post-cardiac catheterization
Number of Participants with Hyperkalemia
Serum potassium increased to \> 5.5 mg/dL at 48-72hrs
Time frame: 48 - 72 hours post-cardiac catheterization
Creatinine clearance
Change in Creatinine clearance at 48-72hrs
Time frame: 48 - 72 hours post-cardiac catheterization
Death, Myocardial Infarction, Stroke, Congestive Heart Failure, dialysis, major bleeding, minor bleeding, hypertension, re-hospitalization at 48-72hrs
Death, Myocardial Infarction, Stroke, Congestive Heart Failure, dialysis, major bleeding, minor bleeding, hypertension, re-hospitalization at 48-72hrs
Time frame: 48 - 72 hours post-cardiac catheterization
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