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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00209404
Enrollment
50
Registered
2005-09-21
Start date
2005-07-31
Completion date
Unknown
Last updated
2007-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

MDCT, Coronary Artery, Heart Rate, Image Quality, Diagnostic Quality

Brief 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.

Interventions

DRUGIodixanol 320 mg I/Ml

Sponsors

GE Healthcare
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frame
Change in mean heart rate

Secondary

MeasureTime frame
Image quality
Diagnostic quality
Overall diagnostic information
Frequency and intensity of adverse events

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026