Effect of Continuing vs. Discontinuing ACE Inhibitors on Renal Function After Coronary Angiography

Tanta University44 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Contrast-Induced Nephropathy Coronary Angiography

Interventions

Continuing RamiprilDRUG

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.

Withholding RamiprilDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change From Baseline in Serum Creatinine at 72 Hours Post-Angiography

CIN defined as ≥0.5 mg/dL or ≥25% rise in serum creatinine from baseline.

Time frame: Baseline and 72 hours post-angiography

Secondary Outcomes

Change in NGAL and SOD levels (pre vs post)

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.

Time frame: Baseline and 72 hours post-angiography

Incidence of Hyperkalemia After Coronary 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.

Time frame: Within 72 hours post-angiography

Incidence of Clinical Adverse Events Within 72 Hours

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.