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NCT Number: NCT07294911

Predictors of Contrast-induced Acute Renal Injury in Patients With Acute Coronary Syndrome

This observational study aims to identify predictors of contrast-induced acute kidney injury (CI-AKI) in patients with acute coronary syndrome undergoing percutaneous coronary intervention. Clinical, laboratory, and procedural factors will be analyzed to determine their association with the development of CI-AKI. The findings may help improve risk stratification and preventive strategies in this high-risk population.

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Key information

About this study

This prospective observational study investigates predictors of contrast-induced acute kidney injury (CI-AKI) among patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). The study was conducted from November 2024 to June 2025 at a tertiary cardiac center.

Patients with ACS who underwent coronary angiography or PCI were enrolled consecutively. Clinical characteristics, laboratory parameters, hydration status, use of nephrotoxic drugs, and type and volume of contrast media were recorded. Serum creatinine levels were measured before and 48-72 hours after contrast exposure, and CI-AKI was defined according to KDIGO criteria.

The primary objective is to identify independent predictors of CI-AKI using multivariate analysis. Secondary objectives include evaluation of short-term outcomes, such as in-hospital complications and renal function recovery at 90 days. The results are expected to improve understanding of CI-AKI risk in real-world ACS patients and to support preventive strategies in interventional cardiology.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age ≥ 18 years

Diagnosis of acute coronary syndrome (STEMI or NSTEMI) confirmed by clinical, ECG, and laboratory findings

Undergoing coronary angiography or percutaneous coronary intervention with intravascular contrast administration

Provided informed consent to participate in the study

Availability of baseline and follow-up serum creatinine values

Exclusion criteria

Known chronic kidney disease stage 4 or 5 (eGFR < 30 mL/min/1.73 m²) or on dialysis

Hemodynamic instability not related to acute coronary syndrome (e.g., septic shock)

Exposure to intravenous contrast within the previous 7 days

Use of nephrotoxic drugs (e.g., aminoglycosides, amphotericin B) within 72 hours prior to contrast exposure

Active infection or inflammatory disease affecting renal function

Pregnancy or breastfeeding

Refusal or inability to provide informed consent

Treatment and study plan

Observational Data Collection

Other

Data collected from routine clinical care to evaluate predictors of contrast-induced acute kidney injury after PCI. No intervention applied.

Primary outcomes

  1. Change in serum creatinine at 90 days

    Time frame: 90 days after contrast exposure

    Change in serum creatinine level compared to baseline at 90-day follow-up after contrast exposure, to evaluate renal function recovery or persistent impairment.

  2. Incidence of Contrast-Induced Acute Kidney Injury (CI-AKI)

    Time frame: Within 72 hours after contrast exposure

    Occurrence of contrast-induced acute kidney injury (CI-AKI) defined as an increase in serum creatinine of ≥0.3 mg/dL (≥26.5 µmol/L) or ≥50% from baseline within 48-72 hours after exposure to iodinated contrast media, according to KDIGO criteria.

Secondary outcomes

  1. Changes in plasma TIMP-2 concentration

    Time frame: 2 hours after contrast exposure

    Assessment of urinary TIMP-2 levels 2 hours after contrast exposure to detect early markers of renal tubular injury

Sponsors and collaborators

Lead sponsor

Karaganda Medical University

Other

Registry information

Official study title

Predictors of Contrast-Induced Acute Kidney Injury in Patients With Acute Coronary Syndrome

Acronym: PC-AKI-ACS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2025
Registry last updated
Dec 19, 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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