Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Coronary Angiography
This study has been completed.
Sponsor:
GE Healthcare
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00209430
First received: September 13, 2005
Last updated: October 30, 2007
Last verified: October 2007
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
MedlinePlus related topics:
Coronary Artery Disease
Drug Information available for:
Iodixanol
U.S. FDA Resources
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 |
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 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 |
ClinicalTrials.gov processed this record on May 22, 2013