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

Sponsor
I.M. Sechenov First Moscow State Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04163484
Collaborator
(none)
150
1
64.5
2.3

Study Details

Study Description

Brief 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Contrast-associated Acute Kidney Injury in Patients With Different Types of Coronary Artery Disease
Actual Study Start Date :
Jan 15, 2019
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
May 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Stable coronary artery disease

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

ST-elevation myocardial infarction

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

Non-ST-elevation myocardial infarction

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

Outcome Measures

Primary Outcome Measures

  1. Contrast associated acute kidney injury [48-72 hours]

    Number of patients with contrast associated kidney injury after contrast exposure

Secondary Outcome Measures

  1. Overall mortality [1 year]

  2. Cardiovascular mortality [1 year]

  3. Myocardial infarction [1 year]

    Number of patients with myocardial infarction

  4. Stroke [1 year]

  5. Repeat revascularization [1 year]

    PCI or CABG

  6. Repeat hospitalisation [1 year]

  7. Acute decompensation of heart failure [1 year]

    Number of patients with acute decompensation of heart failure

  8. Chronic kidney disease progression [1 year]

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

  9. New-onset dialysis [1 year]

    Number of patients with new-onset dialysis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sechenov University Moscow Russian Federation

Sponsors and Collaborators

  • I.M. Sechenov First Moscow State Medical University

Investigators

  • Study Director: Olga Mironova, MD PhD, I. M. Sechenov First Moscow State Medical University (Sechenov University)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Olga Mironova, MD PhD Associate Professor, I.M. Sechenov First Moscow State Medical University
ClinicalTrials.gov Identifier:
NCT04163484
Other Study ID Numbers:
  • 11/2019
First Posted:
Nov 14, 2019
Last Update Posted:
Jan 14, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Olga Mironova, MD PhD Associate Professor, I.M. Sechenov First Moscow State Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2022