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

NCT07184918 | Completed

• 1 other identifier: ACEI-RF-2024
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Contrast-Induced Nephropathy; Coronary Angiography; Acute Kidney Injury

Keywords

CIN; Ramipril; Renal Function; Cardiac Catheterization; Nephrotoxicity; Renal Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 72 hours post-angiography

Secondary Outcomes (3)

• Change in NGAL and SOD levels (pre vs post)

  Baseline and 72 hours post-angiography

• Incidence of Hyperkalemia After Coronary Angiography

  Within 72 hours post-angiography

• Incidence of Clinical Adverse Events Within 72 Hours

  Within 72 hours post-angiography

Study Arms (2)

Arm 1: Withholding Ramipril

EXPERIMENTAL

Discontinue Ramipril 48 hours prior to coronary angiograph.

Drug: Withholding Ramipril

Arm 2: Continuing Ramipril

ACTIVE COMPARATOR

Continue Ramipril throughout the peri-procedural period.

Drug: Continuing Ramipril

Interventions

Continuing Ramipril DRUG

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.

Also known as: Tritace

Arm 2: Continuing Ramipril

Withholding Ramipril DRUG

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.

Also known as: Tritace

Arm 1: Withholding Ramipril

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥18 years) scheduled for elective coronary angiography
• Currently on ACE inhibitor (Ramipril)
• Serum creatinine ≤1.5 mg/dL

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Pharmacy Tanta university

Tanta, Gharbia Governorate, 31527, Egypt

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Ramipril

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dalia R El-Afify, Assoc Prof

  Tanta University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: September 22, 2025
• Study Start: February 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)