Acute Kidney Injury, Contrast-Induced Nephropathy, Coronary Angiography
Conditions
Keywords
CIN, Ramipril, Renal Function, Cardiac Catheterization, Nephrotoxicity, Renal Biomarkers
Brief summary
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.
Detailed description
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.
Interventions
DRUGContinuing Ramipril
Participants in this group will continue taking Ramipril at their usual dose before, during, and after the coronary angiography. The objective is to evaluate the renal effects of uninterrupted ACE inhibitor therapy during contrast exposure.
DRUGWithholding Ramipril
Participants in this group will stop taking Ramipril 48 hours before the angiography procedure and resume it 72 hours after. This intervention is used to evaluate whether temporarily withholding ACE inhibitors reduces the risk of contrast-induced nephropathy.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Adults (≥18 years) scheduled for elective coronary angiography * Currently on ACE inhibitor (Ramipril) * Serum creatinine ≤1.5 mg/dL
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Serum Creatinine at 72 Hours Post-Angiography | Baseline and 72 hours post-angiography | CIN defined as ≥0.5 mg/dL or ≥25% rise in serum creatinine from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in NGAL and SOD levels (pre vs post) | Baseline and 72 hours post-angiography | Change in serum NGAL (Neutrophil Gelatinase-Associated Lipocalin) and SOD (Superoxide Dismutase) levels measured before and 72 hours after coronary angiography. These biomarkers are used to assess early tubular injury and oxidative stress respectively. Comparison will be made between intervention arms to determine whether ACE inhibitor withholding reduces renal cellular stress. |
| Incidence of Hyperkalemia After Coronary Angiography | Within 72 hours post-angiography | Proportion of participants who develop hyperkalemia (defined as serum potassium \>5.5 mmol/L) within 72 hours after coronary angiography. Comparison will be made between participants who continued ACE inhibitor therapy and those who withheld it to evaluate the impact of ACEI on electrolyte disturbance. |
| Incidence of Clinical Adverse Events Within 72 Hours | Within 72 hours post-angiography | Occurrence of adverse clinical outcomes including dialysis requirement, myocardial infarction, stroke, or new-onset heart failure within 72 hours of coronary angiography. Events will be monitored and compared between the two intervention groups to evaluate safety related to ACE inhibitor continuation or withholding. |
Countries
Egypt
Outcome results
None listed