Renal Effects of Three Iodinated Contrast Media (CM) in Patients at Risk Undergoing Coronary Angiography - Full Text View

Renal Effects of Three Iodinated Contrast Media (CM) in Patients at Risk Undergoing Coronary Angiography

This study has been terminated.

Sponsored by:	GE Healthcare
Information provided by:	GE Healthcare
ClinicalTrials.gov Identifier:	NCT00335101

Purpose

The study is to evaluate and compare the effects on kidney function of three iodinated contrast media (CM) in patients at risk of kidney damage evaluating serum creatinine (Scr) concentrations up to three days after CM administration.

Condition	Intervention	Phase
Coronary Artery Disease (CAD) Renal Impairment Diabetes Mellitus	Drug: Iodixanol, Ioversol, Iopromide	Phase IV

MedlinePlus related topics:

Coronary Artery Disease Diabetes

ChemIDplus related topics:

Iodixanol Iopromide Ioversol Creatinine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study

Further study details as provided by GE Healthcare:

Primary Outcome Measures:

Primary endpoint:
Maximum peak increase in SCr from baseline up to day 3.
Secondary endpoints:
Change in SCr from baseline to day 2 and to day 3
Number of subjects with contrast-induced nephropathy (CIN)
Quality of diagnostic information

Secondary Outcome Measures:

Coronary Artery Disease (CAD)
Renal Impairment
Diabetes mellitus

Estimated Enrollment:	384
Study Start Date:	June 2006

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 DM (type I or II) and renal impairment (RI), defined as 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 transplantation or with CrCl < 20 mL/min will not be included.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335101

Locations


United States, New Jersey
	GE Healthcare
	Princeton, New Jersey, United States, 08540

Germany
	GE Healthcare
	Munich, Germany, 80807

Sponsors and Collaborators

GE Healthcare

Investigators


Study Director:	Marc Pignot, PhD	GE Healthcare

Study Director:	Johnny Gibbs, Jr., CCRA	GE Healthcare

More Information

Study ID Numbers:	GE-012-091
First Received:	June 6, 2006
Last Updated:	May 14, 2007
ClinicalTrials.gov Identifier:	NCT00335101
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Germany: Federal Institute for Drugs and Medical Devices; Italy: The Italian Medicines Agency; Austria: Federal Ministry for Health and Women

Keywords provided by GE Healthcare:

Coronary Artery Disease (CAD), Renal Impairment, Serum creatinine (SCr), Iodixanol, Ioversol, Iopromide, Contrast Induced Nephropathy (CIN)

Study placed in the following topic categories:

Arterial Occlusive Diseases

Metabolic Diseases

Heart Diseases

Myocardial Ischemia

Diabetes Mellitus

Vascular Diseases

Endocrine System Diseases

Ischemia

Arteriosclerosis

Coronary Disease

Endocrinopathy

Kidney Diseases

Metabolic disorder

Glucose Metabolism Disorders

Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 14, 2008