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CompletedNCT00209404Updated Oct 31, 2007

Iodixanol in Multidetector-Row Computed Tomography-Coronary Angiography (MDCT-CA)

A Phase 4 interventional study of Iodixanol 320 mg I/Ml in Coronary Artery Disease, sponsored by GE Healthcare. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-10-31.

Sponsored by GE Healthcare · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Image quality in coronary artery computed tomography is influenced by the heart rate variation during the examination. The purpose of this clinical trial is to investigate the change in heart rate following injection of a contrast medium called Visipaque™ (iodixanol). Image quality and diagnostic quality of the examination will be evaluated.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • MDCT
  • Coronary Artery
  • Heart Rate
  • Image Quality
  • Diagnostic Quality
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 50 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

GE Healthcare is the lead sponsor of 168 studies on the registry; 19 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects with low to moderate suspicion of coronary artery disease referred for retrospective electrocardiogram (ECG)-gated multidetector row computed tomography coronary angiography and with a heart rate >75 beats per minute (bpm) will be included.

Exclusion criteria

Exclusion Criteria:

  • Subjects who take medications that slow down the heart rate or present cardiac arrhythmia at rest will not be included.
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants

Interventions

  • DrugIodixanol 320 mg I/Ml
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What researchers measure

Primary outcomes

  1. Change in mean heart rate

Secondary outcomes

  1. Image quality

  2. Diagnostic quality

  3. Overall diagnostic information

  4. Frequency and intensity of adverse events

07

Study locations

1 site
  • Amersham Health S.A.
    Velizy Cedex, 78457, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00209404
Lead sponsor
GE Healthcare
First posted
Sep 21, 2005
Start date
Jul 2005
Last update
Oct 31, 2007

Study contacts

Jean-Paul Antonini
study director · GE Healthcare
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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