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: May 1, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Cardio Renal Safety in High-risk Elderly Subjects Undergoing a Coronary CATH With or Without PCI.
Drug: GE-145
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader. [ Time Frame: After the imaging date for either Ioforminol or Iopamidol. ] [ Designated as safety issue: No ]
    Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales.


Secondary Outcome Measures:
  • 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.

    Summary of Treatment-Emergent Adverse Events (TEAE) in greater than of equal to 2% of Subjects.


  • Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections [ Time Frame: 2, 6 and 24 hours post Ioforminol and Iopamidol adminstration ] [ Designated as safety issue: Yes ]
    Analyzing the number of subjects with renal biomarker-based contrast-induced acute kidney injury (CI-AKI).


Enrollment: 284
Study Start Date: November 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GE 145 320mg I/ml injection 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
Active Comparator: Iopamidol 370mg I/ml injection 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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females 65 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.
  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: NCT01252810

Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
i3 Statprobe
Medpace, Inc.
Biomedical Systems
Rules-Based Medicine (RBM)
Investigators
Study Director: Rubin Sheng, M.D. GE Healthcare
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01252810     History of Changes
Other Study ID Numbers: GE 145-002
Study First Received: December 1, 2010
Results First Received: February 6, 2014
Last Updated: May 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GE Healthcare:
CATH Catheterization
CI-AKI Contrast-induced acute kidney injury
DM Diabetes mellitus
eGFR Estimated glomerular filtration rate
MDRD Modification of Diet in Renal Disease
NYHA New York Heart Association
PCI Percutaneous coronary intervention
SCr Serum creatinine

Additional relevant MeSH terms:
Iopamidol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014