Assessment of the Effect of Atorvastatin on Prevention of CIN in Patients Undergoing Coronary Angiography (CIN)

April 10, 2014 updated by: peyman bidram, Isfahan University of Medical Sciences

Atorvastatin and Prevention of Contrast Induced Nephropathy Following Coronary Angiography

As the effect of statin use before the angiography to prevent contrast induced nephropathy (CIN) is not well-known, the aim of the current study is to assess the effect of atorvastatin on prevention of CIN in patients undergoing coronary angiography.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • having chronic stable angina who were referred for coronary angiography
  • non-pregnant female subjects
  • no history of diabetes mellitus
  • no history of renal failure
  • no history of single kidney
  • no history of cardiogenic shock
  • no history of unstable angina
  • no history of myocardial infarction
  • no history of hypersensitivity to statins
  • no history of previous intravascular contrast injection during one month before admission

Exclusion Criteria:

  • glomerular filtration rate (GFR) <60
  • cardiogenic shock

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo group
taking atorvastatin like placebo 12 hours before the procedure
No Intervention: long term statin group
taking atorvastatin for a long time before entering the study (their routine treatment)
Experimental: preoperation statin group
taking atorvastatin 12 hours before the procedure
Drug: Atorvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contrast induced nephropathy (CIN) incidence
Time Frame: 48 hours after the procedure
CIN is determined as an increase in post-procedural serum creatinine of > 0.5 mg/dl or > 25% from baseline in the absence of any other causes
48 hours after the procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
serum creatinine (Cr) level
Time Frame: 48 hours after the procedure
48 hours after the procedure

Collaborators and Investigators

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

Sponsor

Isfahan University of Medical Sciences

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, 2012

Primary Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

April 5, 2014

First Submitted That Met QC Criteria

April 10, 2014

First Posted (Estimate)

April 14, 2014

Study Record Updates

Last Update Posted (Estimate)

April 14, 2014

Last Update Submitted That Met QC Criteria

April 10, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Grant number: 392172

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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