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Completed

NCT Number: NCT01252810

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

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Key information

Conditions

Chronic Renal Insufficiency Cardiovascular Diseases Chronic Disease Congestive Heart Failure Diabete Mellitus Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Heart Diseases Heart Failure Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GE Healthcare

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GE-145

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.

Other names: Ioforminol

Primary outcomes

  1. 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.

    Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales.

Secondary outcomes

  1. 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.

    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.

  2. 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

    Analyzing the number of subjects with renal biomarker-based contrast-induced acute kidney injury (CI-AKI).

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

  • Biomedical Systems
  • Medpace, Inc.
  • Rules-Based Medicine, Inc.
  • i3 Statprobe

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 3, 2010
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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