Predictors of Contrast-induced Acute Renal Injury in Patients With Acute Coronary Syndrome (PC-AKI-ACS)

December 8, 2025 updated by: Karaganda Medical University

Predictors of Contrast-Induced Acute Kidney 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
    • Qaraghandy Oblysy
      • Karaganda, Qaraghandy Oblysy, Kazakhstan, 100000
        • Karaganda Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population includes adult patients (≥18 years old) with ST-segment elevation myocardial infarction (STEMI) who underwent emergency percutaneous coronary intervention with intravascular contrast. Participants were prospectively enrolled between November 2024 and June 2025.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute Coronary Syndrome Patients Undergoing PCI
Patients admitted with acute coronary syndrome (STEMI or NSTEMI) who underwent coronary angiography or percutaneous coronary intervention. Clinical, laboratory, and procedural data were collected to identify predictors of contrast-induced acute kidney injury (CI-AKI). No additional interventions were applied beyond standard clinical care.
Other: Observational data collection
Data collected from routine clinical care to evaluate predictors of contrast-induced acute kidney injury after PCI. No intervention applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days after contrast exposure
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.
Within 72 hours after contrast exposure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 hours after contrast exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karaganda Medical University

Investigators

  • Principal Investigator: Miras M Mugazov, MD, PhD, Karaganda Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2024

Primary Completion (Actual)

June 2, 2025

Study Completion (Actual)

September 2, 2025

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Actual)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI-AKI-STEMI-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to privacy and institutional policy restrictions. Aggregate results may be available upon reasonable request after publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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