NCT00382317

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2006

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

November 26, 2008

Status Verified

November 1, 2008

Enrollment Period

1.5 years

First QC Date

September 28, 2006

Last Update Submit

November 25, 2008

Conditions

Diagnostic Imaging

Keywords

MSCT indications

Interventions

IobitridolDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AKH

Vienna, 1090, Austria

Location

CHU Charles Nicolle

Rouen, 76031, France

Location

MeSH Terms

Interventions

iobitridol

Study Officials

  • Corinne Dubourdieu, PhD

    Guerbet

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 28, 2006

First Posted

September 29, 2006

Study Start

August 1, 2006

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

November 26, 2008

Record last verified: 2008-11

Locations

FR(1)AU(1)