A Clinical Study of Iobitridol in Patients Undergoing Multislice Computed Tomography (CT) Abdominal Angiography
Phase 4
Completed
- Conditions
- Diagnostic Imaging
- Registration Number
- NCT00382317
- Lead Sponsor
- Guerbet
- Brief Summary
This is a clinical study of iobitridol in patients undergoing multislice CT (MSCT) abdominal angiography.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Iobitridol's contrast enhancement in multislice CT abdominal angiography?
How does Iobitridol compare to standard-of-care contrast agents like Iohexol in MSCT abdominal angiography outcomes?
Are there biomarkers that predict optimal Iobitridol dosing or response in patients with renal impairment undergoing CT angiography?
What adverse events were reported in Guerbet's Phase 4 Iobitridol trial for MSCT abdominal angiography and how were they managed?
What are the pharmacokinetic profiles of Iobitridol versus other non-ionic iodinated contrast media in vascular imaging studies?
Trial Locations
- Locations (2)
AKH
🇦🇹Vienna, Austria
CHU Charles Nicolle
🇫🇷Rouen, France
AKH🇦🇹Vienna, Austria