Contrast-induced Acute Kidney InjuryNCT04666389
The Role of Statins in the Prevention of Contrast-induced Acute Kidney Injury in Patients With Cardiovascular Diseases
A study testing Atorvastatin in people with Contrast-induced Acute Kidney Injury and Cardiovascular Diseases, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast-induced Acute Kidney Injury, Cardiovascular Diseases
- What is being tested?
- Atorvastatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 15 Oct 2020to 10 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Indications for computer tomography with intravenous contrast media administration
- Cardiovascular diseases (arterial hypertension, arrhythmia etc)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Atorvastatin
- Keywords
- contrast-induced acute kidney injury, contrast-associated acute kidney injury, contrast media, cardiovascular diseases, computer tomography
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | No statins being used for prevention Receives: Drug: Atorvastatin |
| Low-dose statin therapy | Active comparator | Atorvastatin 40 mg Receives: Drug: Atorvastatin |
| High-dose statin therapy | Active comparator | Atorvastatin 80 mg Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48-72 hours after contrast media administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start15 Oct 2020
- Primary completion31 Dec 2022
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contrast-induced Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Mironova, I.M. Sechenov First Moscow State Medical University
- Investigators
- Olga Mironova, MD PhD, Principal investigator, Sechenov University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666389
- Sponsor's protocol ID
- 09/2020
- Status last verified
- Jan 2023
- First submitted
- 1 Dec 2020
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36286755
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Statins in the Prevention of Contrast-induced Acute Kidney Injury in Patients With Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT04666389
- Acronym / sponsor ID
- 09/2020
- Keywords
- contrast-induced acute kidney injury, contrast-associated acute kidney injury, contrast media, cardiovascular diseases, computer tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: AtorvastatinNo statins being used for prevention |
| Low-dose statin therapy | Active comparator | Drug: AtorvastatinAtorvastatin 40 mg |
| High-dose statin therapy | Active comparator | Drug: AtorvastatinAtorvastatin 80 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Indications for computer tomography with intravenous contrast media administration
- Cardiovascular diseases (arterial hypertension, arrhythmia etc)
Key exclusion criteria (7 listed)
- Pregnancy
- Statin therapy before inclusion in the study
- Acute coronary syndromes
- Contraindications for statins administration
- Patients with chronic kidney disease stages 4-5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinTo 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 | Drug | Control group, High-dose statin therapy, Low-dose statin therapy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 36286755Vasin 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.
- 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.Link provided by the sponsor.
- 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.)Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Mironova, MD PhD principal investigator
Sechenov University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin in people with Contrast-induced Acute Kidney Injury and Cardiovascular Diseases, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast-induced acute kidney injury (time frame: 48-72 hours after contrast media administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04666389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.