Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure

This study has been completed.
Sponsor:
Collaborators:
i3 Statprobe
Medpace, Inc.
Biomedical Systems
Rules-Based Medicine (RBM)
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01252810
First received: December 1, 2010
Last updated: December 18, 2013
Last verified: December 2013

December 1, 2010
December 18, 2013
November 2010
December 2012   (final data collection date for primary outcome measure)
Comparison of the incidence rates of cardio-renal adverse reactions in elderly subjects with at least one additional co-morbidities undergoing coronary catheterization [ Time Frame: Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration. ] [ Designated as safety issue: Yes ]
Comparison of the incidence rates of cardio-renal adverse reactions in elderly subjects with at least one additional co-morbidities undergoing coronary catheterization with or without PCI involving intra-arterial administration of either GE-145 320 mg I/mL Injection or iopamidol 370 mg I/mL.
Same as current
Complete list of historical versions of study NCT01252810 on ClinicalTrials.gov Archive Site
To determine incidence rates of the overall AEs, organ-specific AEs (i.e., delayed skin reactions, general subject comfort, and allergic/immunologic reactions, etc.) and SAEs following administration [ Time Frame: Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration. ] [ Designated as safety issue: Yes ]

To determine incidence rates of the overall AEs, organ-specific AEs (i.e., delayed skin reactions, general subject comfort, and allergic/immunologic reactions, etc.) and SAEs following administration of GE-145 or iopamidol.

To determine incidence rates and onset time of biomarker-based and SCr-based CI-AKI following administration of GE-145 or iopamidol.

Same as current
Not Provided
Not Provided
 
Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure
A Phase 2, Double-Blind, Randomized, Safety Study of GE-145 320 mg I/mL Injection Versus Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Artery Catheterization Procedure

To evaluate cardio-renal and overall safety profile of GE 145 320 mg I/ml Injection when compared to iopamidol 370 mg I/mL. The study will focus on elderly subjects with either chronic renal insufficiency, or diabetes mellitus (DM) requiring drug therapy, or congestive heart failure (CHF) NYHA Class III or greater, who are referred for a coronary catheterization procedure with or without PCI.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Cardio Renal Safety in High-risk Elderly Subjects Undergoing a Coronary CATH With or Without PCI.
Drug: GE-145
GE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration.
Other Name: Ioforminol
  • Experimental: GE 145 320mg I/ml injection
    Intervention: Drug: GE-145
  • Active Comparator: Iopamidol 370mg I/ml injection
    Intervention: Drug: GE-145
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
284
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females 70 years of age with cardiovascular disease who are referred for a coronary catheterization procedure with or without PCI.
  • The subject has at least one of the following comorbidities:
  • 1) Chronic renal insufficiency, (eGFR <60 but 15 mL/min/1.73 m2 according to the MDRD equation) as measured within 2 weeks or at the screening visit;
  • 2) DM diagnosed greater than 6 months prior to study entry and which requires either insulin or anti-hyperglycemic drug therapy;
  • 3) CHF (NYHA) class III or greater measured within 2 weeks of enrollment or at the screening visit.

Exclusion Criteria:

  • The subject has known allergies to either iodine or any ICM.
  • The subject has severe renal insufficiency (eGFR <15 mL/min/1.73 m2 according to the MDRD equation) or is on dialysis.
  • The subject has acute coronary syndrome requiring emergency coronary angiography and/or intervention.
  • The subject is not willing or unable to discontinue metformin (e.g., Glucophage) at the time of the study procedure.
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01252810
GE 045-002
Yes
GE Healthcare
GE Healthcare
  • i3 Statprobe
  • Medpace, Inc.
  • Biomedical Systems
  • Rules-Based Medicine (RBM)
Study Director: Rubin Sheng, M.D. GE Healthcare
GE Healthcare
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP