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

Congestive Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01252810
• Other study ID #: GE 145-002
• Status: Completed
• Phase: Phase 2
• Start date: November 2010
• Est. completion date: December 2012

Study information

• Verified date: August 2018
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Renal Insufficiency
• Congestive Heart Failure
• Diabete Mellitus
• Diabetes Mellitus
• Heart Failure
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	GE Healthcare	Princeton	New Jersey

Sponsors (5)

Lead Sponsor	Collaborator
GE Healthcare	Biomedical Systems, i3 Statprobe, Medpace, Inc., Rules-Based Medicine, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader.	Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales.	After the imaging date for either Ioforminol or Iopamidol.
Secondary	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	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.	Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration.
Secondary	Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections	Analyzing the number of subjects with renal biomarker-based contrast-induced acute kidney injury (CI-AKI).	2, 6 and 24 hours post Ioforminol and Iopamidol adminstration