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

Primary Purpose

Contrast-induced Acute Kidney Injury, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
I.M. Sechenov First Moscow State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contrast-induced Acute Kidney Injury focused on measuring contrast-induced acute kidney injury, contrast-associated acute kidney injury, contrast media, cardiovascular diseases, computer tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Sechenov University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Control group

Low-dose statin therapy

High-dose statin therapy

Arm Description

No statins being used for prevention

Atorvastatin 40 mg

Atorvastatin 80 mg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 1, 2020
Last Updated
January 24, 2023
Sponsor
I.M. Sechenov First Moscow State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04666389
Brief Title
The Role of Statins in the Prevention of Contrast-induced Acute Kidney Injury in Patients With Cardiovascular Diseases
Official Title
The Role of Statins in the Prevention of Contrast-induced Acute Kidney Injury in Patients With Cardiovascular Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
January 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast-induced Acute Kidney Injury, Cardiovascular Diseases
Keywords
contrast-induced acute kidney injury, contrast-associated acute kidney injury, contrast media, cardiovascular diseases, computer tomography

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
No statins being used for prevention
Arm Title
Low-dose statin therapy
Arm Type
Active Comparator
Arm Description
Atorvastatin 40 mg
Arm Title
High-dose statin therapy
Arm Type
Active Comparator
Arm Description
Atorvastatin 80 mg
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
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
Primary Outcome Measure Information:
Title
Contrast-induced acute kidney injury
Description
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.
Time Frame
48-72 hours after contrast media administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga Mironova, MD PhD
Organizational Affiliation
Sechenov University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sechenov University
City
Moscow
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36286755
Citation
Vasin AA, Mironova OI, Fomin VV. [The atorvastatin effects on the prevention of contrast-induced acute kidney injury during computed tomography with contrast media]. Ter Arkh. 2022 Oct 24;94(9):1057-1061. doi: 10.26442/0403660.2022.09.201845. Russian.
Results Reference
derived
Links:
URL
https://doi.org/10.38109/2225-1685-2022-3-84-88
Description
Vasin AA, Mironova OIu, Fomin VV. The atorvastatin effects on the prevention of contrast-induced acute kidney injury during computed tomography with contrast media. Terapevticheskii Arkhiv (Ter. Arkh.). 2022;94(9):1057-1061.
URL
https://doi.org/10.38109/2225-1685-2022-3-84-88
Description
Vasin A.A., Mironova O.I., Fomin V.V. Intravenous contrast induced acute kidney injury prevention with high doses of statins. Eurasian heart journal. 2022;(3):84-88. (In Russ.)
URL
https://doi.org/10.26442/20751753.2021.12.201162
Description
Vasin AA, Mironova OIu, Fomin VV. Contrast-induced acute kidney injury after computed tomography with contrast media in patients with cardiovascular diseases. Consilium Medicum. 2021;23(12):928-930.

Learn more about this trial

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

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