Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography

Overview

The purpose of this study is to evaluate and compare overall patient comfort profile between an Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients undergoing arteriography of peripheral arteries.

Full Title of Study: “A Phase 4 Randomized, Double-blind Study Comparing Patient Comfort and Safety Between Iodixanol 320 mg I/mL and Iopamidol 370 mg I/mL in Patients Undergoing Peripheral Arteriography”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 2013

Interventions

  • Drug: Iodixanol
    • Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
  • Drug: Iopamidol
    • Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.

Arms, Groups and Cohorts

  • Active Comparator: Active Arm
  • Active Comparator: Comparator Arm

Clinical Trial Outcome Measures

Primary Measures

  • Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography
    • Time Frame: Within 10 minutes post contrast administration.
    • The number of subjects experiencing overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.

Secondary Measures

  • Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography.
    • Time Frame: Within 10 minutes post contrast administration.
    • Overall Image Quality rated as ‘Excellent, Adequate or Poor’ by radiologists blinded to the contrast administration.

Participating in This Clinical Trial

Inclusion Criteria

  • The subject is over 18 years old. – Subjects are referred to undergo a peripheral arteriography as part of their routine clinical care. Exclusion Criteria:

  • The subject has known allergies to iodine or any prior history of adverse reaction to iodinated CM. – The subject received another administration of CM within 24 hours prior to baseline or is scheduled to receive one within the 24 hour follow-up period. – The subject is pregnant or lactating. – The subject is taking metformin (e.g., Glucophage®) but is not willing or unable to discontinue at the time of the study procedure. – The subject manifests thyrotoxicosis or is on dialysis.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • GE Healthcare
  • Collaborator
    • i3 Statprobe
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lauren Lim, PharmD, Study Director, GE Healthcare

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