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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
i3 Statprobe
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01475097
First received: November 3, 2011
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Drug Safety
 Drug: Iodixanol
Drug: Iopamidol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Evaluation of patient discomfort on 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.


Estimated Enrollment: 250
Study Start Date: October 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Arm 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
Active Comparator: Comparator Arm 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475097

Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
i3 Statprobe
Investigators
Study Director: Lauren Lim, PharmD GE Healthcare
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01475097     History of Changes
Other Study ID Numbers: GE-012-098
Study First Received: November 3, 2011
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GE Healthcare:
AE - Adverse event
Arteriography
IA - Intra-arterial
IOCM - Iso-Osmolar Contrast Medium
 LOCM - Low-Osmolar Contrast Medium
Patient Comfort
Body Image Disturbance
Patient

ClinicalTrials.gov processed this record on May 22, 2013