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

October 25, 2019 updated by: Olga Mironova, I.M. Sechenov First Moscow State Medical University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1023

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

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

Description

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1 (5-year prognosis)
Procedure: Iodinated contrast media
Percutaneous coronary intervention with iodinated contest media
Group 2 (1-year prognosis)
Procedure: Iodinated contrast media
Percutaneous coronary intervention with iodinated contest media

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke
Time Frame: 5 years
5 years
Myocardial infarction
Time Frame: 5 years
5 years
Cardiovascular mortality
Time Frame: 5 years
5 years
Overall mortality
Time Frame: 5 years
5 years
GI bleeding
Time Frame: 5 years
5 years
CABG
Time Frame: 5 years
CABG after PCI at enrolment
5 years
PCI
Time Frame: 5 years
Repeat PCI after the enrolment
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.M. Sechenov First Moscow State Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 16, 2012

Primary Completion (ACTUAL)

October 19, 2017

Study Completion (ACTUAL)

December 12, 2018

Study Registration Dates

First Submitted

July 7, 2019

First Submitted That Met QC Criteria

July 7, 2019

First Posted (ACTUAL)

July 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 29, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/13 (Other Grant/Funding Number: Diabetes Australia Millenium Grant)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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