Effect of Continuing vs. Discontinuing ACE Inhibitors on Renal Function After Coronary Angiography
- Conditions
- Contrast-Induced NephropathyCoronary AngiographyAcute Kidney Injury
- Interventions
- Drug: Withholding RamiprilDrug: Continuing Ramipril
- Registration Number
- NCT07184918
- Lead Sponsor
- Tanta University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- Adults (≥18 years) scheduled for elective coronary angiography
- Currently on ACE inhibitor (Ramipril)
- Serum creatinine ≤1.5 mg/dL
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Withholding Ramipril Withholding Ramipril Discontinue Ramipril 48 hours prior to coronary angiograph. Arm 2: Continuing Ramipril Continuing Ramipril Continue Ramipril throughout the peri-procedural period.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Faculty of Pharmacy Tanta university
🇪🇬Tanta, Gharbia Governorate, Egypt
Faculty of Pharmacy Tanta university🇪🇬Tanta, Gharbia Governorate, Egypt