An interventional study of Continuing Ramipril and Withholding Ramipril in Contrast-Induced Nephropathy, Coronary Angiography and Acute Kidney Injury, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-09-22.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
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.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's enrollment of 44 is below the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Discontinue Ramipril 48 hours prior to coronary angiograph.
Drug: Withholding Ramipril
Continue Ramipril throughout the peri-procedural period.
Drug: Continuing Ramipril
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
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
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
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.
Time frame: Within 72 hours post-angiography
Plan to share: No — The data collected in this study are part of a Master's thesis conducted at Tanta University. There is currently no plan to share individual participant data (IPD) due to institutional academic policies and ethical considerations.
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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