A Clinical Study of Iobitridol in Patients Undergoing Multislice Computed Tomography (CT) Abdominal Angiography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-02-29

Brief Summary

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This is a clinical study of iobitridol in patients undergoing multislice CT (MSCT) abdominal angiography.

Detailed Description

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Conditions

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Diagnostic Imaging

Keywords

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MSCT indications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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Iobitridol

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Corinne Dubourdieu, PhD

Role: STUDY_CHAIR

Guerbet

Locations

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AKH

Vienna, , Austria

Site Status

CHU Charles Nicolle

Rouen, , France