Chronic Kidney Diseases, Contrast-induced Nephropathy, Ischemic Heart Disease
Conditions
Keywords
Cardiac catherization, coronary angiography, Coronary angioplasty, chronic kidney disease, contrast induced nephropathy, ACEI, ARBs
Brief summary
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.
Detailed description
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.
Interventions
OTHERContinue ACEI or ARBs ( Enalapril , Ramipril , Valsartan , Candesartan, Losartan )
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 )
OTHERHold ACEI or ARBs
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
Sponsors
An-Najah National University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least one month of continuous therapy with an ACEI or an ARBs and 2. Undergoing elective coronary angiography and 3. Have CKD stage3-4 (15≤GFR\<60 ml/min/1.73 m2).
Exclusion criteria
1. Acute STEMI within 2 weeks 2. NYHA class IV heart failure by history 3. Administration of contrast load within the previous 6 days 4. acute renal failure (ARF) preceding coronary angiography 5. potassium level more than 5.0 meq/l 6. GFR \<15 ml/min/1.73 m2 7. previous percutaneous cardiac catheterization within one month 8. Acute pulmonary edema 9. hemodynamically instability 10. uncontrolled hypertension 11. combination ACEI and ARB therapy 12. Cardiogenic shock 13. Sepsis 14. pregnancy 15. Age below 18 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Contrast induced nephropathy | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum creatinine level | 48 - 72 hours post-cardiac catheterization | Change in serum creatinine at 48-72hrs |
| Number of Participants with Hyperkalemia | 48 - 72 hours post-cardiac catheterization | Serum potassium increased to \> 5.5 mg/dL at 48-72hrs |
| Creatinine clearance | 48 - 72 hours post-cardiac catheterization | Change in Creatinine clearance at 48-72hrs |
| Death, Myocardial Infarction, Stroke, Congestive Heart Failure, dialysis, major bleeding, minor bleeding, hypertension, re-hospitalization at 48-72hrs | 48 - 72 hours post-cardiac catheterization | Death, Myocardial Infarction, Stroke, Congestive Heart Failure, dialysis, major bleeding, minor bleeding, hypertension, re-hospitalization at 48-72hrs |
Countries
Palestinian Territories
Contacts
Primary ContactYunis A Daralammouri, asst. prof.
Backup ContactMurad M Azamtta, MD
Outcome results
None listed