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Clinical Trials/NCT07294911
NCT07294911
Completed
Not Applicable

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

Karaganda Medical University1 site in 1 country88 target enrollmentStarted: November 2, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
88
Locations
1
Primary Endpoint
Change in serum creatinine at 90 days

Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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.

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

  • Changes in plasma TIMP-2 concentration(2 hours after contrast exposure)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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