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

Phase 4

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT00209404
• Lead Sponsor: GE Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-08-18
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-30
• Last Update Posted: 2007-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in mean heart rate

Secondary Outcome Measures

Name	Time	Method
Image quality
Diagnostic quality
Overall diagnostic information
Frequency and intensity of adverse events

Trial Locations

Locations (1)

Amersham Health S.A.; 🇫🇷 Velizy Cedex, France

Amersham Health S.A.

🇫🇷Velizy Cedex, France