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Completed

NCT Number: NCT07184918

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

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.

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Key information

Conditions

Contrast-induced Nephropathy Acute Kidney Injury Coronary Angiography Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Pharmacy Tanta university

Tanta, Gharbia Governorate, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Tritace

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.

Other names: Tritace

Primary outcomes

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

    Time frame: Baseline and 72 hours post-angiography

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

Secondary outcomes

  1. Change in NGAL and SOD levels (pre vs post)

    Time frame: 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.

  2. Incidence of Hyperkalemia After Coronary Angiography

    Time frame: 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.

  3. Incidence of Clinical Adverse Events Within 72 Hours

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Clinical Study Evaluating the Effect of Continuing or Discontinuing Angiotensin-Converting Enzyme Inhibitor on Renal Function in Patients Undergoing Coronary Angiography

Acronym: ACEI-RF

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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