Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Coronary Angiography

This study has been completed.
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00209430
First received: September 13, 2005
Last updated: October 30, 2007
Last verified: October 2007
  Purpose

The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.


Condition Intervention Phase
Coronary Artery Disease
Renal Impairment
Drug: Iodixanol 320 mgI/mL
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title.

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Peak increase in SCr
  • Incidence of contrast media-induced nephropathy from baseline up to day 3.

Secondary Outcome Measures:
  • SCr concentrations up to days 3 and 7
  • image quality
  • occurrence of adverse events and their severity and relationship with the contrast media.

Estimated Enrollment: 408
Study Start Date: August 2005
Detailed Description:

GEHC has decided not to provide this detail

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a combination of diabetes mellitus (type I or II) and renal impairment, defined as serum creatinine (SCr ) ≥150 µmol/L (1.7 mg/dL) for men and ≥133 µmol/L (1.5 mg/dL) for women or creatinine clearance (CrCl) ≤ 50 mL/min calculated according to Cockroft-Gault formula, referred for coronary angiography with or without PCI.

Exclusion Criteria:

  • Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not allowed. Subjects undergoing dialysis or kidney transplant will not be included.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209430

Locations
Sweden
Amersham Health S.A
Solna, Sweden
Sponsors and Collaborators
GE Healthcare
Investigators
Study Director: Caroline Widlund, BSc RN GE Healthcare
Study Director: Johnny Gibbs, Jr., B.S., CCRA 609-514-6809
  More Information

No publications provided by GE Healthcare

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00209430     History of Changes
Other Study ID Numbers: DXV405
Study First Received: September 13, 2005
Last Updated: October 30, 2007
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: National Institute of Health
Norway: Norwegian Medicines Agency
Spain: Ministry of Health
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
India:DCGI/ Drug Controller General of India

Keywords provided by GE Healthcare:
Iodixanol
Iopamidol
coronary angiography
Contrast media-induced nephropathy

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Kidney Diseases
Urologic Diseases
Contrast Media
Iodixanol
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014