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

Completed

• Conditions: Acute Kidney Injury; Angina, Unstable; STEMI - ST Elevation Myocardial Infarction; Angina, Stable; Coronary Artery Disease; NSTEMI - Non-ST Segment Elevation MI; Contrast-induced Nephropathy
• Interventions: Other: Iodinated contrast

• Registration Number: NCT04163484
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-15
• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-11-12
• Study First Posted: 2019-11-14
• Primary Completion: 2022-12-30
• Study Completion: 2024-05-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-ST-elevation myocardial infarction	Iodinated contrast	-
Stable coronary artery disease	Iodinated contrast	-
ST-elevation myocardial infarction	Iodinated contrast	-

Primary Outcome Measures

Name	Time	Method
Contrast associated acute kidney injury	48-72 hours	Number of patients with contrast associated kidney injury after contrast exposure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sechenov University; 🇷🇺 Moscow, Russian Federation