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Contrast-medium Induced Nephrotoxicity in Patients Undergoing Coronary Angiography - Iodixanol Versus Iopromide

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00823628
First Posted: January 15, 2009
Last Update Posted: July 7, 2010
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.
Information provided by:
Seoul National University Bundang Hospital
  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, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with underlying kidney disease and decreased kidney function. The investigators 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
Chronic Renal Insufficiency Coronary Angiography Drug: contrast agent (iopromide) Drug: contrast agent (iodixanol) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Contrast-medium Induced Nephrotoxicity Between Iodixanol and Iopromide in Patients With Renal Insufficiency Undergoing Coronary Angiography

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang 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) [ Time Frame: 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 [ Time Frame: days 1 and 2 ]

Estimated Enrollment: 420
Study Start Date: February 2009
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: iopromide Drug: contrast agent (iopromide)
coronary angiography using the allocated contrast agent
Experimental: iodixanol Drug: contrast agent (iodixanol)
coronary angiography using the allocated contrast agent

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 iopromide, an nonionic, monomeric LOCM, in patients with renal impairment.
  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who undergo coronary catheterization
  • creatinine clearance rates ≤ 60 mL/min using the Cockcroft-Gault formula

Exclusion Criteria:

  • pregnancy or lactation
  • having received contrast media within 7 days of study entry
  • emergent coronary angiography
  • acute renal failure or end-stage renal disease requiring dialysis
  • history of hypersensitivity reaction to contrast media
  • unstable hemodynamic states such as cardiogenic shock, pulmonary edema or needing mechanical ventilation
  • multiple myeloma
  • 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
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 ClinicalTrials.gov identifier (NCT number): NCT00823628


Locations
Korea, Republic of
Cardiovascular Center, Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Study Director: Tae-Jin Youn, MD, PhD Facility: Cardiovascular Center, Seoul National University Bundang Hospital
  More Information

Responsible Party: Tae-Jin Youn / Associate professor, Cardiovascular Center, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT00823628     History of Changes
Other Study ID Numbers: B-0902/069-003
First Submitted: January 14, 2009
First Posted: January 15, 2009
Last Update Posted: July 7, 2010
Last Verified: April 2009

Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases