Drug Safety
Conditions
Keywords
AE - Adverse event, Arteriography, IA - Intra-arterial, IOCM - Iso-Osmolar Contrast Medium, LOCM - Low-Osmolar Contrast Medium, Patient Comfort, Body Image Disturbance, Patient
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.
Interventions
DRUGIodixanol
Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
DRUGIopamidol
Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
Sponsors
i3 Statprobe
GE Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
255 subjects were enrolled in this study. Two (2) subjects did not complete the study. Total number of subjects that completed the study was 253.
Pre-assignment details
Total of 255 subjects enrolled in this study. 2 subjects discontinued the study prior to contrast administration. Therefore, 253 subjects completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Iodixanol 320mgI/mL Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration. | 127 |
| Iopamidol 370mgI/mL Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration. | 126 |
| Total | 253 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Iodixanol 320mgI/mL | Iopamidol 370mgI/mL | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 72 Participants | 58 Participants | 130 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants | 68 Participants | 123 Participants |
| Age, Continuous | 64.5 years STANDARD_DEVIATION 13.34 | 62.0 years STANDARD_DEVIATION 15.3 | 63.2 years STANDARD_DEVIATION 14.38 |
| Region of Enrollment Germany | 38 participants | 39 participants | 77 participants |
| Region of Enrollment Spain | 57 participants | 58 participants | 115 participants |
| Region of Enrollment United Kingdom | 5 participants | 5 participants | 10 participants |
| Region of Enrollment United States | 27 participants | 24 participants | 51 participants |
| Sex: Female, Male Female | 49 Participants | 45 Participants | 94 Participants |
| Sex: Female, Male Male | 78 Participants | 81 Participants | 159 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 127 | 3 / 126 |
| serious Total, serious adverse events | 2 / 127 | 2 / 126 |
Outcome results
Primary
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.
Population: 249 subjects completed assessments, for overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.124 subjects received Iodixanol and 125 subjects received Iopamidol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Iodixanol 320mgI/mL | Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography | Discomfort | 53 participants |
| Iodixanol 320mgI/mL | Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography | Heat | 48 participants |
| Iodixanol 320mgI/mL | Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography | Pain | 5 participants |
| Iopamidol 370mgI/mL | Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography | Discomfort | 92 participants |
| Iopamidol 370mgI/mL | Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography | Heat | 82 participants |
| Iopamidol 370mgI/mL | Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography | Pain | 21 participants |
Secondary
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.
Population: A recruitment error occurred with a subject in each treatment group. Therefore, the subject's efficacy data were excluded from this efficacy analysis.~This resulted in a total of 126 Iodixanol subjects and a total 125 Iopamidol subjects were used in the imaging analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Iodixanol 320mgI/mL | Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography. | Excellent | 109 participants |
| Iodixanol 320mgI/mL | Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography. | Adequate | 16 participants |
| Iodixanol 320mgI/mL | Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography. | Poor | 1 participants |
| Iopamidol 370mgI/mL | Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography. | Excellent | 103 participants |
| Iopamidol 370mgI/mL | Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography. | Adequate | 19 participants |
| Iopamidol 370mgI/mL | Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography. | Poor | 3 participants |