CClinicalTrials.gg
CompletedNCT04163484Updated Oct 8, 2024

Contrast-associated Acute Kidney Injury in Patients With Different Types of Coronary Artery Disease

An observational study in Coronary Artery Disease, Angina, Unstable and Angina, Stable, sponsored by I.M. Sechenov First Moscow State Medical University. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-08.

Sponsored by I.M. Sechenov First Moscow State Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
156
Ages
18 Years to 80 Years
Sex
All
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Study summary

The goal of the study is to assess the prevalence of contrast-associated acute kidney injury in patients with stable coronary artery disease, ST-elevation myocardial infarction and unstable angina/NSTEMI, assess the risk factors of contrast-induced acute kidney injury development and the influence of contrast-induced kidney injury on 1-year prognosis.

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Conditions studied

  • Coronary Artery Disease
  • Angina, Unstable
  • Angina, Stable
  • STEMI - ST Elevation Myocardial Infarction
  • NSTEMI - Non-ST Segment Elevation MI
  • Contrast-induced Nephropathy
  • Acute Kidney Injury

Keywords

  • coronary artery disease
  • iodinated contrast media
  • stable angina
  • unstable angina
  • STEMI
  • NSTEMI
  • PCI
  • acute kidney injury
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In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's enrollment of 156 is close to the median of 150 across 773 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

I.M. Sechenov First Moscow State Medical University is the lead sponsor of 133 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Males and females aged 18-80, who have the indication for treatment of CAD with PCI requiring the intra-arterial injection of iodinated contrast-media

Inclusion criteria

  • Males and females aged 18-80
  • Stable CAD receiving optimal medical treatment requiring PCI or STEMI or NSTEMI
  • Intra-arterial injection of iodinated contrast media
  • Informed consent

Exclusion criteria

Exclusion Criteria:

  • Age less than 18
  • Pregnancy, lactation
  • Refuse to sign the informed consent
  • Contraindications for PCI
  • Other conditions affecting prognosis (oncology, liver failure etc)
  • CKD stage 4-5
  • Patients receiving nephrotoxic drugs
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
156 participants (actual)
Patient registry
No

Groups and cohorts

  • Stable coronary artery disease

    Other: Iodinated contrast

  • ST-elevation myocardial infarction

    Other: Iodinated contrast

  • Non-ST-elevation myocardial infarction

    Other: Iodinated contrast

Interventions

  • OtherIodinated contrast

    Intra-arterial injection of iodinated contrast media during percutaneous coronary intervention

06

What researchers measure

Primary outcomes

  1. Contrast associated acute kidney injury

    Number of patients with contrast associated kidney injury after contrast exposure

    Time frame: 48-72 hours

Secondary outcomes

  1. Overall mortality

    Time frame: 1 year

  2. Cardiovascular mortality

    Time frame: 1 year

  3. Myocardial infarction

    Number of patients with myocardial infarction

    Time frame: 1 year

  4. Stroke

    Time frame: 1 year

  5. Repeat revascularization

    PCI or CABG

    Time frame: 1 year

  6. Repeat hospitalisation

    Time frame: 1 year

  7. Acute decompensation of heart failure

    Number of patients with acute decompensation of heart failure

    Time frame: 1 year

  8. Chronic kidney disease progression

    Progression of chronic kidney disease in patients with decreased glomerular filtration rate on inclusion

    Time frame: 1 year

  9. New-onset dialysis

    Number of patients with new-onset dialysis

    Time frame: 1 year

07

Study locations

1 site
  • Sechenov University
    Moscow, Russian Federation
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04163484
Lead sponsor
I.M. Sechenov First Moscow State Medical University
Responsible party
Olga Mironova (MD PhD Associate Professor, I.M. Sechenov First Moscow State Medical University) — Principal investigator
First posted
Nov 14, 2019
Start date
Jan 15, 2019
Primary completion
Dec 30, 2022
Completion
May 30, 2024
Last update
Oct 8, 2024

Study contacts

Olga Mironova, MD PhD
study director · I. M. Sechenov First Moscow State Medical University (Sechenov University)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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