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

This study has been completed.
Information provided by:
GE Healthcare Identifier:
First received: August 18, 2005
Last updated: October 30, 2007
Last verified: October 2007
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.

Condition Intervention Phase
Coronary Artery Disease Drug: Iodixanol 320 mg I/Ml Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Resource links provided by NLM:

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Change in mean heart rate

Secondary Outcome Measures:
  • Image quality
  • Diagnostic quality
  • Overall diagnostic information
  • Frequency and intensity of adverse events

Estimated Enrollment: 50
Study Start Date: July 2005

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00209404

Amersham Health S.A.
Velizy Cedex, France, 78457
Sponsors and Collaborators
GE Healthcare
Study Director: Jean-Paul Antonini GE Healthcare
  More Information Identifier: NCT00209404     History of Changes
Other Study ID Numbers: DXV407
Study First Received: August 18, 2005
Last Updated: October 30, 2007

Keywords provided by GE Healthcare:
Coronary Artery
Heart Rate
Image Quality
Diagnostic Quality

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on September 21, 2017