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

Coronary Artery Disease Clinical Trial

Official title:

GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00209430
• Other study ID #: DXV405
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: October 30, 2007
• Start date: August 2005

Study information

• Verified date: October 2007
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the EnvironmentFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesItaly: National Institute of HealthNorway: Norwegian Medicines AgencySpain: Ministry of HealthSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyIndia:DCGI/ Drug Controller General of India
• Study type: Interventional

Clinical Trial Summary

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.

Description:

GEHC has decided not to provide this detail

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• Iodixanol 320 mgI/mL

Locations

Country	Name	City	State
Sweden	Amersham Health S.A	Solna

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak increase in SCr
Primary	Incidence of contrast media-induced nephropathy from baseline up to day 3.
Secondary	SCr concentrations up to days 3 and 7
Secondary	image quality
Secondary	occurrence of adverse events and their severity and relationship with the contrast media.