Stable AnginaNCT04014153
CI-AKI in Patients With Stable CAD and Comorbidities. Are we Doing Better?
An observational study of Stable Angina and Acute Kidney Injury, run by I.M. Sechenov First Moscow State Medical University.
Trial summary
Patients aged 18-89 with stable CAD and comorbidities receiving optimal medical treatment requiring PCI with iodinated contrast media. The aim of the study is to assess the prevalence of contrast-induced AKI in 2012-2013 and 2017 cohorts and to evaluate the potential risk factors of CI-AKI to better guide the… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Stable Angina, Acute Kidney Injury, Contrast-induced Nephropathy
- What is being tested?
- Iodinated contrast media
- Type of treatment
- Surgery or procedure
- How many people
- 1,023 participants
- Where
- No sites listed yet
- Study dates
- 16 May 2012to 12 Dec 2018
- 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 89 years
- All sexes
- Adult, Older adult
Study population: Both genders suffering from stable coronary artery disease, requiring percutaneous coronary intervention with intra-arterial iodinated contrast injection
Who may be able to join
- Informed consent
- Male and female patients 18 y. o. and older
- Verified stable coronary artery disease (CAD)
- Receiving optimal medical treatment and requiring percutaneous coronary intervention (PCI) with iodinated contrast media
Who cannot join
- Pregnancy, lactation
- Conditions affecting the prognosis (kidney failure, liver failure, oncology)
- Acute coronary syndrome (ACS)
- Stroke
- Contraindications to PCI
- Therapy with nephrotoxic drugs during the enrolment which cannot be stopped
- Refusal to sign the informed consent
About this study
Official title: The Impact of Comorbidity as a Risk Factor of Acute Kidney Injury (AKI) in Patients With Stable Coronary Artery Disease (CAD)
Patients aged 18-89 with stable CAD and comorbidities receiving optimal medical treatment requiring PCI with iodinated contrast media.
The aim of the study is to assess the prevalence of contrast-induced AKI in 2012-2013 and 2017 cohorts and to evaluate the potential risk factors of CI-AKI to better guide the prevention in patients of higher risk.
- Being tested
- Iodinated contrast media
- Keywords
- acute kidney injury, coronary artery disease, contrast-induced acute kidney injury, comorbidity, CI-AKI, stable CAD
- Medical subject headings
- Angina, Stable, Acute Kidney Injury, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodinated contrast mediaProcedure or surgery
Percutaneous coronary intervention with iodinated contest media
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (5-year prognosis) | Not described Receives: Procedure: Iodinated contrast media | |
| Group 2 (1-year prognosis) | Not described Receives: Procedure: Iodinated contrast media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall mortality
Measured: 5 years
Cardiovascular mortality
Measured: 5 years
Myocardial infarction
Measured: 5 years
Stroke
Measured: 5 years
GI bleeding
Measured: 5 years
CABG
CABG after PCI at enrolment
Measured: 5 years
PCI
Repeat PCI after the enrolment
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start16 May 2012
- Primary completion19 Oct 2017
- Study completion12 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stable AnginaStudies 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
- 1,023 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014153
- Sponsor's protocol ID
- 1/13
- Status last verified
- Oct 2019
- First submitted
- 7 Jul 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mironova OIu. [Contrast substances-induced nephropathy]. Ter Arkh. 2013;85(6):90-5. Russian.
PubMed 23875199Mironova OI, Deev AD, Lakotka PG, Fomin VV. [Anemia as a risk factor of contrast-associated acute kidney injury]. Ter Arkh. 2020 Dec 15;92(12):48-52. doi: 10.26442/00403660.2020.12.200450. Russian.
PubMed 33720573Mironova OI, Staroverov II, Sivakova OA, Deev AD, Fomin VV. [Contrast-induced acute kidney injury in chronic coronary artery disease patients with diabetes mellitus and obesity]. Ter Arkh. 2020 Nov 24;92(10):29-33. doi: 10.26442/00403660.2020.10.000753. Russian.
PubMed 33346476
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Comorbidity as a Risk Factor of Acute Kidney Injury (AKI) in Patients With Stable Coronary Artery Disease (CAD)
- ClinicalTrials.gov ID
- NCT04014153
- Acronym / sponsor ID
- 1/13
- Keywords
- acute kidney injury, coronary artery disease, contrast-induced acute kidney injury, comorbidity, CI-AKI, stable CAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,023 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 16 May 2012 (actual)
- Primary completion
- 19 Oct 2017 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 10 Jul 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.
Patients aged 18-89 with stable CAD and comorbidities receiving optimal medical treatment requiring PCI with iodinated contrast media.
The aim of the study is to assess the prevalence of contrast-induced AKI in 2012-2013 and 2017 cohorts and to evaluate the potential risk factors of CI-AKI to better guide the prevention in patients of higher risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (5-year prognosis) | – | Procedure: Iodinated contrast media |
| Group 2 (1-year prognosis) | – | Procedure: Iodinated contrast media |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Both genders suffering from stable coronary artery disease, requiring percutaneous coronary intervention with intra-arterial iodinated contrast injection
Key inclusion criteria (4 listed)
- Informed consent
- Male and female patients 18 y. o. and older
- Verified stable coronary artery disease (CAD)
- Receiving optimal medical treatment and requiring percutaneous coronary intervention (PCI) with iodinated contrast media
Key exclusion criteria (7 listed)
- Pregnancy, lactation
- Conditions affecting the prognosis (kidney failure, liver failure, oncology)
- Acute coronary syndrome (ACS)
- Stroke
- Contraindications to PCI
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 contrast mediaPercutaneous coronary intervention with iodinated contest media | Procedure or surgery | Group 1 (5-year prognosis), Group 2 (1-year prognosis) |
Primary outcome
Overall mortality
Time frame: 5 years
Cardiovascular mortality
Time frame: 5 years
Myocardial infarction
Time frame: 5 years
Stroke
Time frame: 5 years
GI bleeding
Time frame: 5 years
CABG
Time frame: 5 years
CABG after PCI at enrolment
PCI
Time frame: 5 years
Repeat PCI after the enrolment
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 29 Oct 2019.
- Background: PubMed 23875199Mironova OIu. [Contrast substances-induced nephropathy]. Ter Arkh. 2013;85(6):90-5. Russian.
- Derived from this study: PubMed 33720573Mironova OI, Deev AD, Lakotka PG, Fomin VV. [Anemia as a risk factor of contrast-associated acute kidney injury]. Ter Arkh. 2020 Dec 15;92(12):48-52. doi: 10.26442/00403660.2020.12.200450. Russian.
- Derived from this study: PubMed 33346476Mironova OI, Staroverov II, Sivakova OA, Deev AD, Fomin VV. [Contrast-induced acute kidney injury in chronic coronary artery disease patients with diabetes mellitus and obesity]. Ter Arkh. 2020 Nov 24;92(10):29-33. doi: 10.26442/00403660.2020.10.000753. Russian.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable Angina and Acute Kidney Injury, run by I.M. Sechenov First Moscow State Medical University.
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 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Overall mortality (time frame: 5 years). The study lists 7 primary outcomes in all. 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 NCT04014153, which also lists 3 linked publications.
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 29 Oct 2019.