NCT04163484

Brief 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 kidney injury on 1-year prognosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

4 years

First QC Date

October 25, 2019

Last Update Submit

October 3, 2024

Conditions

Coronary Artery DiseaseAngina, UnstableAngina, StableSTEMI - ST Elevation Myocardial InfarctionNSTEMI - Non-ST Segment Elevation MIContrast-induced NephropathyAcute Kidney Injury

Keywords

coronary artery diseaseiodinated contrast mediastable anginaunstable anginaSTEMINSTEMIPCIacute kidney injury

Outcome Measures

Primary Outcomes (1)

  • Contrast associated acute kidney injury

    Number of patients with contrast associated kidney injury after contrast exposure

    48-72 hours

Secondary Outcomes (9)

  • Overall mortality

    1 year

  • Cardiovascular mortality

    1 year

  • Myocardial infarction

    1 year

  • Stroke

    1 year

  • Repeat revascularization

    1 year

  • +4 more secondary outcomes

Study Arms (3)

Stable coronary artery disease

Other: Iodinated contrast

ST-elevation myocardial infarction

Other: Iodinated contrast

Non-ST-elevation myocardial infarction

Other: Iodinated contrast

Interventions

Iodinated contrastOTHER

Intra-arterial injection of iodinated contrast media during percutaneous coronary intervention

Non-ST-elevation myocardial infarctionST-elevation myocardial infarctionStable coronary artery disease

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sechenov University

Moscow, Russia

Location

Related Links

MeSH Terms

Conditions

Coronary Artery DiseaseAngina, UnstableAngina, StableST Elevation Myocardial InfarctionNon-ST Elevated Myocardial InfarctionAcute Kidney Injury

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial InfarctionInfarctionIschemiaPathologic ProcessesNecrosisRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Olga Mironova, MD PhD

    I. M. Sechenov First Moscow State Medical University (Sechenov University)

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD Associate Professor

Study Record Dates

First Submitted

October 25, 2019

First Posted

November 14, 2019

Study Start

January 15, 2019

Primary Completion

December 30, 2022

Study Completion

May 30, 2024

Last Updated

October 8, 2024

Record last verified: 2024-10

Locations

RU(1)