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

NCT ID: NCT04666389

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2023-01-10

Brief Summary

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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

Detailed Description

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Conditions

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Contrast-induced Acute Kidney Injury Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control group

No statins being used for prevention

Group Type PLACEBO_COMPARATOR

Atorvastatin

Intervention Type DRUG

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

Low-dose statin therapy

Atorvastatin 40 mg

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

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

High-dose statin therapy

Atorvastatin 80 mg

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role lead

Responsible Party

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Olga Mironova

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olga Mironova, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Sechenov University

Locations

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Sechenov University

Moscow, , Russia

Site Status

Countries

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Russia

References

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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.

Reference Type DERIVED
PMID: 36286755 (View on PubMed)

Related Links

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https://doi.org/10.38109/2225-1685-2022-3-84-88

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.

https://doi.org/10.38109/2225-1685-2022-3-84-88

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.)

https://doi.org/10.26442/20751753.2021.12.201162

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.

Other Identifiers

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09/2020

Identifier Type: -

Identifier Source: org_study_id

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