CompletedNCT04014153Updated Oct 29, 2019

CI-AKI in Patients With Stable CAD and Comorbidities. Are we Doing Better?

An observational study in Stable Angina, Acute Kidney Injury and Contrast-induced Nephropathy, sponsored by I.M. Sechenov First Moscow State Medical University. Completed. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2019-10-29.

Sponsored by I.M. Sechenov First Moscow State Medical University · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 1,023
Ages: 18 Years to 89 Years
Sex: All

Study 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 prevention in patients of higher risk.

Conditions studied

Stable Angina
Acute Kidney Injury
Contrast-induced Nephropathy

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Keywords

acute kidney injury
coronary artery disease
contrast-induced acute kidney injury
comorbidity
CI-AKI
stable CAD

In context

Angina, Stable

349 studies on the registry are indexed under Angina, Stable; 57 are open to participants now.

This study's enrollment of 1,023 is above the median of 500 across 101 observational studies indexed under Angina, Stable.

Browse Angina, Stable studies →

Lead sponsor

I.M. Sechenov First Moscow State Medical University is the lead sponsor of 137 studies on the registry; 28 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 89 Years
Sexes eligible: All
Sampling method: Probability sample

Study population

Both genders suffering from stable coronary artery disease, requiring percutaneous coronary intervention with intra-arterial iodinated contrast injection

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 1,023 participants (actual)
Patient registry: No

Groups and cohorts

Group 1 (5-year prognosis)
Procedure: Iodinated contrast media
Group 2 (1-year prognosis)
Procedure: Iodinated contrast media

Interventions

ProcedureIodinated contrast media
Percutaneous coronary intervention with iodinated contest media

What researchers measure

Primary outcomes

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
CABG after PCI at enrolment
Time frame: 5 years
PCI
Repeat PCI after the enrolment
Time frame: 5 years

Study locations

No study locations are listed for this record.

References and documents

Publications

Mironova OIu. [Contrast substances-induced nephropathy]. Ter Arkh. 2013;85(6):90-5. Russian. PubMed 23875199 ↗
Mironova 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 33720573 ↗
Mironova 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 ↗

Individual participant data

Plan to share: Undecided

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2012 to primary completion in Oct 2017, 65 months.

Of 45 non-industry observational studies under Angina, Stable, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 32. This study's 65 months is above that.

Counting every sponsor, half of 54 studies reached it within 47 months; a quarter within 27 and three quarters within 79.

How these figures are worked out, and which studies are left out of them.

Registered: Jul 7, 2019
First posted: Jul 10, 2019
StartActual: May 16, 2012
Primary completionActual: Oct 19, 2017
CompletionActual: Dec 12, 2018
Last update: Oct 29, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Oct 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04014153
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Responsible party: Olga Mironova (Principal Investigator, I.M. Sechenov First Moscow State Medical University) — Principal investigator
First posted: Jul 10, 2019
Start date: May 16, 2012
Primary completion: Oct 19, 2017
Completion: Dec 12, 2018
Last update: Oct 29, 2019

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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