Diagnostic Imaging
Conditions
Keywords
MSCT indications
Brief summary
This is a clinical study of iobitridol in patients undergoing multislice CT (MSCT) abdominal angiography.
Interventions
DRUGIobitridol
Sponsors
Guerbet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Male or female having reached legal majority age and up to 85 years included. * Scheduled for an aorta and abdominal arterial tree evaluation by MSCT, either for pre-therapeutic evaluation or for post-surgical control or follow-up (including patients with prosthetic vascular material). * Female of childbearing potential must have effective contraception (contraceptive pill or intra-uterine device), or be surgically sterilised, or post-menopausal (minimum 12 months amenorrhea) or must have a documented negative urine and/or blood pregnancy test at screening.
Exclusion criteria
* Patients with overt non-compensated heart failure. * Patients with hemodynamic instability. * Patients with ESC (European Society of Cardiology)/ESH (European Society of Hypertension) grade 3 hypertension (SBP \[systolic blood pressure) over or equal to 180 mm Hg or DBP \[diastolic blood pressure\] over or equal to 110 mm Hg) * Patients with known severe renal failure (defined as creatinine clearance \< 30 ml/min as calculated by the Cockroft and Gault formula). * Patients who have received diuretic or biguanide treatment during the 48 hours preceding the MSCT scan. * Patients with known thyreotoxicosis. * Patients with history of immediate or delayed major hypersensitivity reaction to iodinated contrast media.
Countries
Austria, France
Outcome results
None listed