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OpenTrials
Completed

NCT Number: NCT04666389

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sechenov University

Moscow, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

atorvastatin

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

Primary outcomes

  1. Contrast-induced acute kidney injury

    Time frame: 48-72 hours after contrast media administration

    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.

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Dec 14, 2020
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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