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

NCT ID: NCT01252810

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-12-31

Brief 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.

Conditions

Chronic Renal Insufficiency; Diabete Mellitus; Congestive Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

GE 145 320mg I/ml injection

Group Type: EXPERIMENTAL

GE-145

Intervention Type: DRUG

GE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration.

Iopamidol 370mg I/ml injection

Group Type: ACTIVE_COMPARATOR

GE-145

Intervention Type: DRUG

GE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Ioforminol

Eligibility 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

i3 Statprobe

INDUSTRY

Sponsor Role: collaborator

Medpace, Inc.

INDUSTRY

Sponsor Role: collaborator

Biomedical Systems

INDUSTRY

Sponsor Role: collaborator

Rules-Based Medicine, Inc.

INDUSTRY

Sponsor Role: collaborator

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rubin Sheng, M.D.

Role: STUDY_DIRECTOR

GE Healthcare

Locations

GE Healthcare

Princeton, New Jersey, United States

Countries

United States

Other Identifiers

GE 145-002

Identifier Type: -

Identifier Source: org_study_id