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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00247325
Recruitment Status : Completed
First Posted : November 1, 2005
Last Update Posted : November 30, 2006
Information provided by:
Seoul National University Hospital

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Kidney Failure Drug: Iodixanol(Drug) Phase 4

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  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Renal Toxicity Evaluation and Comparison Between Visipaque (Iodixanol) and Hexabrix (Ioxaglate) in Renal Insufficiency Undergoing Coronary Angiography: The RECOVER Study, A Randomized Controlled Trial
Study Start Date : January 2004
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Iodixanol

Primary Outcome Measures :
  1. 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 :
  1. 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

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00247325

Korea, Republic of
Seoul National University Hospital , Cardiovascular Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
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 of Results: Identifier: NCT00247325     History of Changes
Other Study ID Numbers: 144-가-24
First Posted: November 1, 2005    Key Record Dates
Last Update Posted: November 30, 2006
Last Verified: January 2005

Keywords provided by Seoul National University Hospital:
Kidney failure
Contrast media

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases