Coronary Artery DiseaseNCT04163484
Contrast-associated Acute Kidney Injury in Patients With Different Types of Coronary Artery Disease
An observational study of Coronary Artery Disease and Angina, Unstable, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
The goal of the study is to assess the prevalence of contrast-associated acute kidney injury in patients with stable coronary artery disease, ST-elevation myocardial infarction and unstable angina/NSTEMI, assess the risk factors of contrast-induced acute kidney injury development and the influence of contrast-induced… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Angina, Unstable, Angina, Stable
- What is being tested?
- Iodinated contrast
- Type of treatment
- Injection or infusion
- How many people
- 156 participants
- Where
- 1 siteRussia
- Study dates
- 15 Jan 2019to 30 May 2024
- Phase
- Observational
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: Males and females aged 18-80, who have the indication for treatment of CAD with PCI requiring the intra-arterial injection of iodinated contrast-media
Who may be able to join
- Males and females aged 18-80
- Stable CAD receiving optimal medical treatment requiring PCI or STEMI or NSTEMI
- Intra-arterial injection of iodinated contrast media
- Informed consent
Who cannot join
- Age less than 18
- Pregnancy, lactation
- Refuse to sign the informed consent
- Contraindications for PCI
- Other conditions affecting prognosis (oncology, liver failure etc)
- CKD stage 4-5
- Patients receiving nephrotoxic drugs
Trial locations and contacts
1 site in 1 country.
About this study
The goal of the study is to assess the prevalence of contrast-associated acute kidney injury in patients with stable coronary artery disease, ST-elevation myocardial infarction and unstable angina/NSTEMI, assess the risk factors of contrast-induced acute kidney injury development and the influence of contrast-induced kidney injury on 1-year prognosis.
- Conditions
- Coronary Artery Disease, Angina, Unstable, Angina, Stable, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, Contrast-induced Nephropathy
- Being tested
- Iodinated contrast
- Keywords
- coronary artery disease, iodinated contrast media, stable angina, unstable angina, STEMI, NSTEMI, PCI, acute kidney injury
- Medical subject headings
- Coronary Artery Disease, Angina, Unstable, Angina, Stable, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodinated contrastOther
Intra-arterial injection of iodinated contrast media during percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| Stable coronary artery disease | Not described Receives: Other: Iodinated contrast | |
| ST-elevation myocardial infarction | Not described Receives: Other: Iodinated contrast | |
| Non-ST-elevation myocardial infarction | Not described Receives: Other: Iodinated contrast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast associated acute kidney injury
Number of patients with contrast associated kidney injury after contrast exposure
Measured: 48-72 hours
Secondary outcomes (9)
Overall mortality
Measured: 1 year
Cardiovascular mortality
Measured: 1 year
Myocardial infarction
Number of patients with myocardial infarction
Measured: 1 year
Stroke
Measured: 1 year
Repeat revascularization
PCI or CABG
Measured: 1 year
Repeat hospitalisation
Measured: 1 year
Acute decompensation of heart failure
Number of patients with acute decompensation of heart failure
Measured: 1 year
Chronic kidney disease progression
Progression of chronic kidney disease in patients with decreased glomerular filtration rate on inclusion
Measured: 1 year
New-onset dialysis
Number of patients with new-onset dialysis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start15 Jan 2019
- Primary completion30 Dec 2022
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 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, Study director, I. M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163484
- Sponsor's protocol ID
- 11/2019
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2019
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-associated Acute Kidney Injury in Patients With Different Types of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04163484
- Acronym / sponsor ID
- 11/2019
- Conditions
- Coronary Artery Disease, Angina, Unstable, Angina, Stable, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, Contrast-induced Nephropathy
- Keywords
- coronary artery disease, iodinated contrast media, stable angina, unstable angina, STEMI, NSTEMI, PCI, acute kidney injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 14 Nov 2019 (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 goal of the study is to assess the prevalence of contrast-associated acute kidney injury in patients with stable coronary artery disease, ST-elevation myocardial infarction and unstable angina/NSTEMI, assess the risk factors of contrast-induced acute kidney injury development and the influence of contrast-induced kidney injury on 1-year prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stable coronary artery disease | – | Other: Iodinated contrast |
| ST-elevation myocardial infarction | – | Other: Iodinated contrast |
| Non-ST-elevation myocardial infarction | – | Other: Iodinated contrast |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Males and females aged 18-80, who have the indication for treatment of CAD with PCI requiring the intra-arterial injection of iodinated contrast-media
Key inclusion criteria (4 listed)
- Males and females aged 18-80
- Stable CAD receiving optimal medical treatment requiring PCI or STEMI or NSTEMI
- Intra-arterial injection of iodinated contrast media
- Informed consent
Key exclusion criteria (7 listed)
- Age less than 18
- Pregnancy, lactation
- Refuse to sign the informed consent
- Contraindications for PCI
- Other conditions affecting prognosis (oncology, liver failure etc)
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 |
|---|---|---|
| Iodinated contrastIntra-arterial injection of iodinated contrast media during percutaneous coronary intervention | Other | Non-ST-elevation myocardial infarction, ST-elevation myocardial infarction, Stable coronary artery disease |
Primary outcome
Contrast associated acute kidney injury
Time frame: 48-72 hours
Number of patients with contrast associated kidney injury after contrast exposure
9 secondary outcomes
Overall mortality
Time frame: 1 year
Cardiovascular mortality
Time frame: 1 year
Myocardial infarction
Time frame: 1 year
Stroke
Time frame: 1 year
Repeat revascularization
Time frame: 1 year
Repeat hospitalisation
Time frame: 1 year
Acute decompensation of heart failure
Time frame: 1 year
Chronic kidney disease progression
Time frame: 1 year
New-onset dialysis
Time frame: 1 year
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 8 Oct 2024.
- Kuznetsov VA, Mironova OIu, Gritsanchuk AM, Fomin VV. Contrast-associated acute kidney injury after percutaneous coronary interventions in patients with acute coronary syndrome: a real-world study. Consilium Medicum. 2022;24(10):713-717Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 study director
I. M. Sechenov First Moscow State Medical University (Sechenov University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Angina, Unstable, 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 4 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 8 Oct 2024. 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. 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 associated acute kidney injury (time frame: 48-72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2024.