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

NCT07294911 | Completed

• 1 other identifier: CI-AKI-STEMI-2025
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Contrast-Induced Acute Kidney Injury

Keywords

Contrast-induced nephropathy; Contrast-induced acute kidney injury; Acute coronary syndrome; Percutaneous coronary intervention; STEMI; NSTEMI; Risk factors; Predictors; Renal dysfunction; CI-AKI

Outcome Measures

Primary Outcomes (2)

• Change in serum creatinine at 90 days

  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)

  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 Outcomes (1)

• Changes in plasma TIMP-2 concentration

  2 hours after contrast exposure

Study Arms (1)

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

Interventions

Observational data collection OTHER

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

Acute Coronary Syndrome Patients Undergoing PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karaganda Medical University: lead

Study Sites (1)

Karaganda Medical University

Karaganda, Qaraghandy Oblysy, 100000, Kazakhstan

Location

Related Publications (11)

• Koyner JL, Shaw AD, Chawla LS, Hoste EA, Bihorac A, Kashani K, Haase M, Shi J, Kellum JA; Sapphire Investigators. Tissue Inhibitor Metalloproteinase-2 (TIMP-2)⋅IGF-Binding Protein-7 (IGFBP7) Levels Are Associated with Adverse Long-Term Outcomes in Patients with AKI. J Am Soc Nephrol. 2015 Jul;26(7):1747-54. doi: 10.1681/ASN.2014060556. Epub 2014 Dec 22.

  PMID: 25535301 BACKGROUND

• Martin-Cleary C, Sanz AB, Avello A, Sanchez-Nino MD, Ortiz A. NephroCheck at 10: addressing unmet needs in AKI diagnosis and risk stratification. Clin Kidney J. 2023 Jun 22;16(9):1359-1366. doi: 10.1093/ckj/sfad146. eCollection 2023 Sep.

  PMID: 37664563 BACKGROUND

• Ortega LM, Heung M. The use of cell cycle arrest biomarkers in the early detection of acute kidney injury. Is this the new renal troponin? Nefrologia (Engl Ed). 2018 Jul-Aug;38(4):361-367. doi: 10.1016/j.nefro.2017.11.013. Epub 2018 Apr 5. English, Spanish.

  PMID: 29627229 BACKGROUND

• Sun Q, Kang Z, Li Z, Xun M. Urinary NGAL, IGFBP-7, and TIMP-2: novel biomarkers to predict contrast medium-induced acute kidney injury in children. Ren Fail. 2022 Dec;44(1):1201-1206. doi: 10.1080/0886022X.2022.2075277.

  PMID: 36120960 BACKGROUND

• Gonzalez-Nicolas MA, Gonzalez-Guerrero C, Goicoechea M, Bosca L, Valino-Rivas L, Lazaro A. Biomarkers in Contrast-Induced Acute Kidney Injury: Towards A New Perspective. Int J Mol Sci. 2024 Mar 19;25(6):3438. doi: 10.3390/ijms25063438.

  PMID: 38542410 BACKGROUND

• Fahling M, Seeliger E, Patzak A, Persson PB. Understanding and preventing contrast-induced acute kidney injury. Nat Rev Nephrol. 2017 Mar;13(3):169-180. doi: 10.1038/nrneph.2016.196. Epub 2017 Jan 31.

  PMID: 28138128 BACKGROUND

• McDonald JS, McDonald RJ, Carter RE, Katzberg RW, Kallmes DF, Williamson EE. Risk of intravenous contrast material-mediated acute kidney injury: a propensity score-matched study stratified by baseline-estimated glomerular filtration rate. Radiology. 2014 Apr;271(1):65-73. doi: 10.1148/radiol.13130775. Epub 2014 Jan 16.

  PMID: 24475854 BACKGROUND

• McDonald RJ, McDonald JS, Carter RE, Hartman RP, Katzberg RW, Kallmes DF, Williamson EE. Intravenous contrast material exposure is not an independent risk factor for dialysis or mortality. Radiology. 2014 Dec;273(3):714-25. doi: 10.1148/radiol.14132418. Epub 2014 Sep 9.

  PMID: 25203000 BACKGROUND

• Hinson JS, Ehmann MR, Fine DM, Fishman EK, Toerper MF, Rothman RE, Klein EY. Risk of Acute Kidney Injury After Intravenous Contrast Media Administration. Ann Emerg Med. 2017 May;69(5):577-586.e4. doi: 10.1016/j.annemergmed.2016.11.021. Epub 2017 Jan 25.

  PMID: 28131489 BACKGROUND

• Breglia A, Godi I, Virzi GM, Guglielmetti G, Iannucci G, De Cal M, Brocca A, Carta M, Giavarina D, Ankawi G, Passannante A, Yun X, Biolo G, Ronco C. Subclinical Contrast-Induced Acute Kidney Injury in Patients Undergoing Cerebral Computed Tomography. Cardiorenal Med. 2020;10(2):125-136. doi: 10.1159/000505422. Epub 2020 Feb 7.

  PMID: 32036364 BACKGROUND

• Suva M, Kala P, Poloczek M, Kanovsky J, Stipal R, Radvan M, Hlasensky J, Hudec M, Brazdil V, Rehorova J. Contrast-induced acute kidney injury and its contemporary prevention. Front Cardiovasc Med. 2022 Dec 6;9:1073072. doi: 10.3389/fcvm.2022.1073072. eCollection 2022.

  PMID: 36561776 BACKGROUND

Related Links

• KDIGO Clinical Practice Guideline for Acute Kidney Injury.
• American College of Cardiology resources on acute coronary syndromes and PCI.
• SPIRIT recommendations for protocol design and structure.
• CONSORT guidelines for clinical trial reporting.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples collected after contrast exposure are stored at -80°C for the analysis of biomarkers of kidney injury, including TIMP-2. No DNA will be extracted or analyzed.

MeSH Terms

Conditions

Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Renal Insufficiency

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Miras M Mugazov, MD, PhD

  Karaganda Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: November 2, 2024
• Primary Completion: June 2, 2025
• Study Completion: September 2, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)