NCT00209404CompletedPhase 4
Iodixanol in Multidetector-Row Computed Tomography-Coronary Angiography (MDCT-CA)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- GE Healthcare
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in mean heart rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •Subjects who take medications that slow down the heart rate or present cardiac arrhythmia at rest will not be included.
Outcomes
Primary Outcomes
Change in mean heart rate
Secondary Outcomes
- Image quality
- Diagnostic quality
- Overall diagnostic information
- Frequency and intensity of adverse events
Investigators
Study Sites (1)
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