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NCT04163484 Clinical Trial

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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04163484
Other study ID # 11/2019
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 15, 2019
Est. completion date May 30, 2024

Study information
Verified date January 2023
Source I.M. Sechenov First Moscow State Medical University
Contact Vladimir Kuznetsov, MD
Phone +79260834936
Email vladimir.86@bk.ru
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date May 30, 2024
Est. primary completion date December 30, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Russian Federation Sechenov University Moscow

Sponsors (1)
Lead Sponsor Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Contrast associated acute kidney injury Number of patients with contrast associated kidney injury after contrast exposure 48-72 hours
Secondary Overall mortality 1 year
Secondary Cardiovascular mortality 1 year
Secondary Myocardial infarction Number of patients with myocardial infarction 1 year
Secondary Stroke 1 year
Secondary Repeat revascularization PCI or CABG 1 year
Secondary Repeat hospitalisation 1 year
Secondary Acute decompensation of heart failure Number of patients with acute decompensation of heart failure 1 year
Secondary Chronic kidney disease progression Progression of chronic kidney disease in patients with decreased glomerular filtration rate on inclusion 1 year
Secondary New-onset dialysis Number of patients with new-onset dialysis 1 year
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