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

NCT ID: NCT00247325

Last Updated: 2006-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2004-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Kidney Failure

Keywords

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Kidney failure Contrast media Iodixanol Ioxaglate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Iodixanol(Drug)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Hyo-Soo Kim, M.D., Ph.D.

Role: STUDY_DIRECTOR

Seoul National University Hospital, Cardiovascular Center

Byung-Hee Oh, M.D., Ph.D.

Role: STUDY_CHAIR

Seoul National University Hospital, Internal Medicine/ Cardiovascular Center

Sang-Ho Jo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital, Cardiovascular Center

Locations

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Seoul National University Hospital , Cardiovascular Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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. doi: 10.1016/j.jacc.2006.06.047. Epub 2006 Aug 17.

Reference Type RESULT
PMID: 16949481 (View on PubMed)

Other Identifiers

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144-가-24

Identifier Type: -

Identifier Source: secondary_id

144-가-24

Identifier Type: -

Identifier Source: org_study_id