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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Drug Safety

Intervention / Treatment
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* Drug: Iodixanol
* Drug: Iopamidol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Arm<br> | Drug: Iodixanol<br>* Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.<br>* Other names: Visipaque;|
| Active Comparator: Comparator Arm<br> | Drug: Iopamidol<br>* Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.<br>* Other names: Isovue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 10 minutes post contrast administration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 10 minutes post contrast administration. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient, AE - Adverse event, Arteriography, IA - Intra-arterial, IOCM - Iso-Osmolar Contrast Medium, LOCM - Low-Osmolar Contrast Medium, Patient Comfort, Body Image Disturbance