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

November 25, 2008 updated by: Guerbet

A Clinical Study of Iobitridol in Multislice CT Abdominal Angiography Indications

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • AKH
  • France
      • Rouen, France, 76031
        • Chu Charles Nicolle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guerbet

Investigators

  • Study Chair: Corinne Dubourdieu, PhD, Guerbet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

September 28, 2006

First Submitted That Met QC Criteria

September 28, 2006

First Posted (Estimate)

September 29, 2006

Study Record Updates

Last Update Posted (Estimate)

November 26, 2008

Last Update Submitted That Met QC Criteria

November 25, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ISO-44-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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