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

Sponsored by:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00247325

Purpose

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	Intervention	Phase
Kidney Failure	Drug: Iodixanol(Drug)	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure

Drug Information available for: Ioxaglic acid Ioxaglate meglumine Ioxaglate sodium Iodixanol

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

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:

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

Study Start Date:	January 2004
Estimated Study Completion Date:	December 2004

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.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247325

Locations

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

Sponsors and Collaborators

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

More Information

Publications:

Jo SH, Youn TJ, Koo BK, Park JS, Kang HJ, Cho YS, Chung WY, Joo GW, Chae IH, Choi DJ, Oh BH, Lee MM, Park YB, Kim HS. Renal toxicity evaluation and comparison between visipaque (iodixanol) and hexabrix (ioxaglate) in patients with renal insufficiency undergoing coronary angiography: the RECOVER study: a randomized controlled trial. J Am Coll Cardiol. 2006 Sep 5;48(5):924-30. Epub 2006 Aug 17.

Study ID Numbers:	144-가-24, 144-가-24
Study First Received:	October 31, 2005
Last Updated:	November 29, 2006
ClinicalTrials.gov Identifier:	NCT00247325 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:

Kidney failure
Contrast media
Iodixanol
Ioxaglate

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on September 10, 2009