CI-AKI in Patients With Stable CAD and Comorbidities. Are we Doing Better?

Completed

• Conditions: Stable Angina; Acute Kidney Injury; Contrast-induced Nephropathy
• Interventions: Procedure: Iodinated contrast media

• Registration Number: NCT04014153
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

Brief Summary

Patients aged 18-89 with stable CAD and comorbidities receiving optimal medical treatment requiring PCI with iodinated contrast media.

The aim of the study is to assess the prevalence of contrast-induced AKI in 2012-2013 and 2017 cohorts and to evaluate the potential risk factors of CI-AKI to better guide the prevention in patients of higher risk.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-16
• Primary Completion: 2017-10-19
• Study Completion: 2018-12-12
• Study First Submitted: 2019-07-07
• Study First Submitted QC: 2019-07-07
• Study First Posted: 2019-07-10
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-25
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1023

Inclusion Criteria

• Informed consent
• Male and female patients 18 y. o. and older
• Verified stable coronary artery disease (CAD)
• Receiving optimal medical treatment and requiring percutaneous coronary intervention (PCI) with iodinated contrast media

Exclusion Criteria

• Pregnancy, lactation
• Conditions affecting the prognosis (kidney failure, liver failure, oncology)
• Acute coronary syndrome (ACS)
• Stroke
• Contraindications to PCI
• Therapy with nephrotoxic drugs during the enrolment which cannot be stopped
• Refusal to sign the informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1 (5-year prognosis)	Iodinated contrast media	-
Group 2 (1-year prognosis)	Iodinated contrast media	-

Primary Outcome Measures

Name	Time	Method
GI bleeding	5 years
Overall mortality	5 years
Stroke	5 years
CABG	5 years	CABG after PCI at enrolment
PCI	5 years	Repeat PCI after the enrolment
Cardiovascular mortality	5 years
Myocardial infarction	5 years