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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT00823628
First received: January 14, 2009
Last updated: July 6, 2010
Last verified: April 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 14, 2009
Last Updated: July 6, 2010
Health Authority: Republic of Korea: Seoul National University Bundang Hospital

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

ClinicalTrials.gov processed this record on June 18, 2013