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NCT00209404 Clinical Trial

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

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00209404
Other study ID # DXV407
Secondary ID
Status Completed
Phase Phase 4
First received August 18, 2005
Last updated October 30, 2007
Start date July 2005

Study information
Verified date October 2007
Source GE Healthcare
Contact n/a
Is FDA regulated No
Health authority France: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesSpain: Ministry of Health and Consumption
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Iodixanol 320 mg I/Ml

Locations
Country Name City State
France Amersham Health S.A. Velizy Cedex

Sponsors (1)
Lead Sponsor Collaborator
GE Healthcare

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in mean heart rate
Secondary Image quality
Secondary Diagnostic quality
Secondary Overall diagnostic information
Secondary Frequency and intensity of adverse events
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