Contrast-induced Nephropathy: Incidence,Risk Factors,Effective Prevention and Management Method

January 26, 2016 updated by: Qian geng, Chinese PLA General Hospital

Chinese People's Liberation Army General Hospital

This review article have included about ten thousand patients undergoing percutaneous coronary intervention (PCI), aim to identify the incidence of CIN in actual, find some new risk factors and the protecting methods for these factors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

About ten thousand patients undergoing percutaneous coronary intervention (PCI) from 2010 to 2015 are included in this study. We collect the data about the SCr of the patients before and after percutaneous coronary intervention, and define CIN as an increase in SCr of 0.5 mg/dl or 25% from baseline between 48 and 72 h after contrast medium exposure. Besides we obtain the data including clinical characteristics, laboratory data (blood and urine tests) for all the patients. The statistical analysis will find some new risk factors.

Study Type

Observational

Enrollment (Actual)

10000

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients undergoing percutaneous coronary intervention (PCI) from 2010 to 2015

Description

Inclusion Criteria:

  1. congestive heart failure: objective evidences for decreased left ventricular eject fraction (LVEF) <= 50%;
  2. moderate to severe chronic kidney disease was defined as an eGFR 15 to 59 mL/min per 1.73 m2, calculated via the abbreviated Modification of Diet in Renal Disease (MDRD) study equation from SCr obtained within 72 hours of enrollment;
  3. patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions.

Exclusion Criteria:

  1. hemodialysis-dependent patients;
  2. complicated with severe short-term progressive disease;
  3. Patients < 18 years;
  4. pregnancy;
  5. emergency cardiac catheterisation (eg, primary percutaneous coronary intervention for ST-segment elevation myocardial infarction);
  6. exposure to radiographic contrast media within the previous 7 days;
  7. acute decompensated heart failure.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contrast induced nephropathy postoperation
Time Frame: 7 days
peak serum creatinine increase of either 0.5 mg/dl or 25% from day 0 through day 7
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite measure of dialysis or main cardiovascular events
Time Frame: 90 days
dialysis, myocardial infarction, heart failure and all-cause death
90 days

Collaborators and Investigators

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

Sponsor

Chinese PLA General Hospital

Investigators

  • Study Chair: Dai Yun Chen, MD, Chinese PLA General Hospital

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

January 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

January 22, 2016

First Submitted That Met QC Criteria

January 26, 2016

First Posted (Estimate)

January 27, 2016

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16qqy

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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