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NCT04666389 Clinical Trial

The Role of Statins in the Prevention of Contrast-induced Acute Kidney Injury in Patients With Cardiovascular Diseases

Cardiovascular Diseases Clinical Trial

Official title:
The Role of Statins in the Prevention of Contrast-induced Acute Kidney Injury in Patients With Cardiovascular Diseases

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04666389
Other study ID # 09/2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2020
Est. completion date January 10, 2023

Study information
Verified date January 2023
Source I.M. Sechenov First Moscow State Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to assess the role of statins and different dosage regimens in the prevention of contrast-induced acute kidney injury in patients with cardiovascular diseases requiring intravenous contrast media administration before computer tomography

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date January 10, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Written informed consent - Indications for computer tomography with intravenous contrast media administration - Cardiovascular diseases (arterial hypertension, arrhythmia etc) Exclusion Criteria: - Pregnancy - Statin therapy before inclusion in the study - Acute coronary syndromes - Contraindications for statins administration - Patients with chronic kidney disease stages 4-5 - Contraindications for computer tomography with contrast media administration - Nephrotoxic drugs use (NSAIDS, vancomycin etc)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Atorvastatin
To compare the preventive role of low- and high-dose statin regimens in the prevention on contrast-induced acute kidney injury in statin-naive patients with cardiovascular diseases undergoing computer tomography with intravenous contrast media administration

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-induced acute kidney injury Contrast induced acute kidney injury is defined as the 25% rise (or 0,5 mg/dl) of serum creatinine from baseline assessed 48 hours after administration of contrast media. 48-72 hours after contrast media administration
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