Acute Coronary SyndromePC-AKI-ACSNCT07294911

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

An observational study of Acute Coronary Syndrome and Contrast-Induced Acute Kidney Injury, run by Karaganda Medical University at 1 site in Kazakhstan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Coronary Syndrome, Contrast-Induced Acute Kidney Injury
What is being tested?: Observational data collection
How many people: 88 participants
Where: 1 siteKazakhstan
Study dates: 2 Nov 2024to 2 Sep 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Kazakhstan1 site

Karaganda Medical University
Karaganda, Qaraghandy Oblysy, 100000

Other trials in Kazakhstan

About this study

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

Read the 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.

Conditions: Acute Coronary Syndrome, Contrast-Induced Acute Kidney Injury
Being tested: Observational data collection
Keywords: Contrast-induced nephropathy, Contrast-induced acute kidney injury, Acute coronary syndrome, Percutaneous coronary intervention, STEMI, NSTEMI, Risk factors, Predictors, Renal dysfunction, CI-AKI
Medical subject headings: Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07294911
Study group	Role	What they receive
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. Receives: Other: Observational data collection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Within 72 hours after contrast exposure

Secondary outcomes (1)

Changes in plasma TIMP-2 concentration
Assessment of urinary TIMP-2 levels 2 hours after contrast exposure to detect early markers of renal tubular injury
Measured: 2 hours after contrast exposure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Nov 20242 Sep 2025

First posted19 Dec 2025
Study start2 Nov 2024
Primary completion2 Jun 2025
Study completion2 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07294911
Sponsor's protocol ID: CI-AKI-STEMI-2025
Acronym: PC-AKI-ACS
Status last verified: Dec 2025
First submitted: 8 Dec 2025
Last updated: 19 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data will not be shared due to privacy and institutional policy restrictions. Aggregate results may be available upon reasonable request after publication.

Publications

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.
PubMed 25535301
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.
PubMed 37664563
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.
PubMed 29627229
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.
PubMed 36120960
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.
PubMed 38542410
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.
PubMed 28138128
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.
PubMed 24475854
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.
PubMed 25203000
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.
PubMed 28131489
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.
PubMed 32036364
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.
PubMed 36561776

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease

All Acute Coronary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Predictors of Contrast-Induced Acute Kidney Injury in Patients With Acute Coronary Syndrome
ClinicalTrials.gov ID: NCT07294911
Acronym / sponsor ID: PC-AKI-ACS / CI-AKI-STEMI-2025
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
Study type: Observational
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Karaganda Medical UniversityUniversity, hospital or other
Study start: 2 Nov 2024 (actual)
Primary completion: 2 Jun 2025 (actual)
Study completion: 2 Sep 2025 (actual)
First posted: 19 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Acute Coronary Syndrome Patients Undergoing PCI	–	Other: Observational data collectionPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Observational data collectionData collected from routine clinical care to evaluate predictors of contrast-induced acute kidney injury after PCI. No intervention applied.	Other	Acute Coronary Syndrome Patients Undergoing PCI

Primary outcome

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.

1 secondary outcome

Changes in plasma TIMP-2 concentration
Time frame: 2 hours after contrast exposure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
Background: PubMed 25535301Koyner 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.
Background: PubMed 37664563Martin-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.
Background: PubMed 29627229Ortega 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.
Background: PubMed 36120960Sun 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.
Background: PubMed 38542410Gonzalez-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.
Background: PubMed 28138128Fahling 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.
Background: PubMed 24475854McDonald 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.
Background: PubMed 25203000McDonald 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.
Background: PubMed 28131489Hinson 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.
Background: PubMed 32036364Breglia 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.
Background: PubMed 36561776Suva 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.
KDIGO Clinical Practice Guideline for Acute Kidney Injury.Link provided by the sponsor.
American College of Cardiology resources on acute coronary syndromes and PCI.Link provided by the sponsor.
SPIRIT recommendations for protocol design and structure.Link provided by the sponsor.
CONSORT guidelines for clinical trial reporting.Link provided by the sponsor.
Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and institutional policy restrictions. Aggregate results may be available upon reasonable request after publication.

Related trials for Acute Coronary Syndrome

Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Miras M Mugazov, MD, PhD principal investigator

Karaganda Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome and Contrast-Induced Acute Kidney Injury, run by Karaganda Medical University at 1 site in Kazakhstan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in serum creatinine at 90 days (time frame: 90 days after contrast exposure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07294911, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.