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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-06-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Contrast-Induced Nephropathy Coronary Angiography Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: Withholding Ramipril

Discontinue Ramipril 48 hours prior to coronary angiograph.

Group Type EXPERIMENTAL

Withholding Ramipril

Intervention Type 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.

Arm 2: Continuing Ramipril

Continue Ramipril throughout the peri-procedural period.

Group Type ACTIVE_COMPARATOR

Continuing Ramipril

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Withholding Ramipril

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.

Intervention Type DRUG

Other Intervention Names

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Tritace Tritace

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No