RECOVER:Comparison of Renal Toxicity Between Visipaque(Iodixanol)and Hexabrix(Ioxaglate)in Renal Insufficiency Undergoing Coronary Angiography

November 29, 2006 updated by: Seoul National University Hospital

Renal Toxicity Evaluation and Comparison Between Visipaque (Iodixanol) and Hexabrix (Ioxaglate) in Renal Insufficiency Undergoing Coronary Angiography: The RECOVER Study, A Randomized Controlled Trial

In the treatment of coronary heart disease which is the major cause of heart attack, direct mechanical treatment with catheters such as the coronary angiography,coronary balloon intervention and stenting intervention are the mainstay of therapy in recent years. In that procedures, we should use the contrast media, and it may cause kidney toxicity especially in the patients with underlying kidney disease and decreased kidney function. We intended to find out which contrast agent has less kidney toxicity in the catheter based treatment of coronary arterial diseases in patients with underlying decreased kidney function

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium (IOCM), may be less nephrotoxic than nonionic, monomeric, low-osmolar contrast media (LOCMs) in high-risk patients. We compared the nephrotoxicity of iodixanol with that of ioxaglate, an ionic, dimeric LOCM, in patients with renal impairment.

Study Type

Interventional

Phase

  • Phase 4

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

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital , Cardiovascular Center

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

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • creatinine clearance rates ≤60 mL/min using the Cockcroft-Gault formula
  • Patients who undergo coronary catheterization
  • Age of 19 or over 19.

Exclusion Criteria:

  • pregnancy
  • lactation
  • having received contrast media within 7 days of study entry
  • emergent coronary angiography
  • acute renal failure
  • end-stage renal disease requiring dialysis
  • history of hypersensitivity reaction to contrast media
  • cardiogenic shock
  • pulmonary edema
  • multiple myeloma
  • mechanical ventilation
  • parenteral use of diuretics
  • use of N-acetylcysteine
  • use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure.

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: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L) during days 1 and 2

Secondary Outcome Measures

Outcome Measure
proportion of patients exhibiting an increase in serum creatinine of >=0.5mg/dL(44.2µmol/L), the proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine, and the mean peak increase in serum creatinine

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Study Director: Hyo-Soo Kim, M.D., Ph.D., Seoul National University Hospital, Cardiovascular Center
  • Study Chair: Byung-Hee Oh, M.D., Ph.D., Seoul National University Hospital, Internal Medicine/ Cardiovascular Center
  • Principal Investigator: Sang-Ho Jo, M.D., Seoul National University Hospital, Cardiovascular Center

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, 2004

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

October 31, 2005

First Submitted That Met QC Criteria

October 31, 2005

First Posted (Estimate)

November 1, 2005

Study Record Updates

Last Update Posted (Estimate)

November 30, 2006

Last Update Submitted That Met QC Criteria

November 29, 2006

Last Verified

January 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 144-가-24

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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