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

January 24, 2023 updated by: Olga Mironova, I.M. Sechenov First Moscow State Medical University
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

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

Study Contact

Study Locations

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

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

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contrast associated acute kidney injury
Time Frame: 48-72 hours
Number of patients with contrast associated kidney injury after contrast exposure
48-72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall mortality
Time Frame: 1 year
1 year
Cardiovascular mortality
Time Frame: 1 year
1 year
Stroke
Time Frame: 1 year
1 year
Myocardial infarction
Time Frame: 1 year
Number of patients with myocardial infarction
1 year
Repeat revascularization
Time Frame: 1 year
PCI or CABG
1 year
Repeat hospitalisation
Time Frame: 1 year
1 year
Acute decompensation of heart failure
Time Frame: 1 year
Number of patients with acute decompensation of heart failure
1 year
Chronic kidney disease progression
Time Frame: 1 year
Progression of chronic kidney disease in patients with decreased glomerular filtration rate on inclusion
1 year
New-onset dialysis
Time Frame: 1 year
Number of patients with new-onset dialysis
1 year

Collaborators and Investigators

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

Sponsor

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)

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.

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)

January 15, 2019

Primary Completion (Actual)

December 30, 2022

Study Completion (Anticipated)

May 30, 2024

Study Registration Dates

First Submitted

October 25, 2019

First Submitted That Met QC Criteria

November 12, 2019

First Posted (Actual)

November 14, 2019

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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