NCT Number: NCT00382317
A Clinical Study of Iobitridol in Patients Undergoing Multislice Computed Tomography (CT) Abdominal Angiography
This is a clinical study of iobitridol in patients undergoing multislice CT (MSCT) abdominal angiography.
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Notify MeKey information
Conditions
Age range
18 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
AKH, Vienna, Austria
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Sponsors and collaborators
Lead sponsor
Guerbet
Industry
Registry information
Official study title
A Clinical Study of Iobitridol in Multislice CT Abdominal Angiography Indications
Important dates
- Study start
- 2006
- Primary completion
- 2008
- Study completion
- 2008
- First posted
- Sep 29, 2006
- Registry last updated
- Nov 26, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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