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

Phase 4

Completed

• Conditions: Drug Safety
• Interventions: Drug: Iopamidol; Drug: Iodixanol

• Registration Number: NCT01475097
• Lead Sponsor: GE Healthcare

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-03
• Study First Submitted QC: 2011-11-16
• Study First Posted: 2011-11-21
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Results First Submitted: 2014-03-11
• Results First Submitted QC: 2014-03-11
• Results First Posted: 2014-04-15
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparator Arm	Iopamidol	-
Active Arm	Iodixanol	-

Primary Outcome Measures

Name	Time	Method
Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography	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 Outcome Measures

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

Trial Locations

Locations (1)

GE Healthcare; 🇺🇸 Princeton, New Jersey, United States