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

GE Healthcare255 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

255

Conditions

Drug Safety

Interventions

IodixanolDRUG

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

IopamidolDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

GE Healthcare

Princeton, New Jersey, United States

Outcomes

Primary Outcomes

Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography

The number of subjects experiencing overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.

Time frame: Within 10 minutes post contrast administration.

Secondary Outcomes

Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography.

Overall Image Quality rated as 'Excellent, Adequate or Poor' by radiologists blinded to the contrast administration.

Time frame: Within 10 minutes post contrast administration.

Data from ClinicalTrials.gov

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