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

This study has been completed.
Sponsor:
Collaborator:
i3 Statprobe
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01475097
First received: November 3, 2011
Last updated: March 11, 2014
Last verified: March 2014

November 3, 2011
March 11, 2014
October 2011
February 2013   (final data collection date for primary outcome measure)
Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography [ Time Frame: Within 10 minutes post contrast administration. ] [ Designated as safety issue: Yes ]
The number of subjects experiencing overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.
Measure Patient Comfort and Safety between Iodixanol 320 mg I/mL and Iopamidol 370 mg I/mL in Patients Undergoing angiography [ Time Frame: The safety and discomfort measurement will start after the initial contrast media injection, within 10 minutes of injection, and then the patient will be followed and evaluated for 24 hours post injection. ] [ Designated as safety issue: Yes ]
Measurement of Patient Comfort and Safety between Iodixanol 320 mg I/mL and Iopamidol 370 mg I/mL in Patients Undergoing angiography of the peripheral arteries as indicated by the intensity of pain and sensations of coldness and/or heat. These will be rated verbally by the patient on a scale of 0 to 10.
Complete list of historical versions of study NCT01475097 on ClinicalTrials.gov Archive Site
Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography. [ Time Frame: Within 10 minutes post contrast administration. ] [ Designated as safety issue: No ]
Overall Image Quality rated as 'Excellent, Adequate or Poor' by radiologists blinded to the contrast administration.
Evaluation of patient discomfort and overall image quality [ Time Frame: At the time the x-ray image is captured, the image will immediately be assessed by the reader using a three-point qualitative scale based solely on the presence or absence of motion artifact. ] [ Designated as safety issue: No ]
Evaluation of patient discomfort on image procedure and overall image quality using a three-point qualitative scale based solely on the presence or absence of motion artifacts.
Not Provided
Not Provided
 
Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Drug Safety
  • 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.
    Other Name: Visipaque
  • 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.
    Other Name: Isovue
  • Active Comparator: Active Arm
    Intervention: Drug: Iodixanol
  • Active Comparator: Comparator Arm
    Intervention: Drug: Iopamidol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
255
February 2013
February 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01475097
GE-012-098
Yes
GE Healthcare
GE Healthcare
i3 Statprobe
Study Director: Lauren Lim, PharmD GE Healthcare
GE Healthcare
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP