Effect of Continuing vs. Discontinuing ACE Inhibitors on Renal Function After Coronary Angiography (ACEI-RF)

Tanta University

Status: Completed

Conditions: Coronary Angiography; Acute Kidney Injury; Contrast-Induced Nephropathy

Treatments: Drug: Continuing Ramipril; Drug: Withholding Ramipril

Study type: Interventional

Funder types: Other

Identifiers

NCT07184918

ACEI-RF-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Arm 1: Withholding Ramipril

Experimental group

Description:

Discontinue Ramipril 48 hours prior to coronary angiograph.

Treatment:

Drug: Withholding Ramipril

Arm 2: Continuing Ramipril

Active Comparator group

Description:

Continue Ramipril throughout the peri-procedural period.

Treatment:

Drug: Continuing Ramipril