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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00209404
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 31, 2007
Information provided by:
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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : July 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Iodixanol
U.S. FDA Resources

Primary Outcome Measures :
  1. Change in mean heart rate

Secondary Outcome Measures :
  1. Image quality
  2. Diagnostic quality
  3. Overall diagnostic information
  4. Frequency and intensity of adverse events

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00209404

Amersham Health S.A.
Velizy Cedex, France, 78457
Sponsors and Collaborators
GE Healthcare
Study Director: Jean-Paul Antonini GE Healthcare Identifier: NCT00209404     History of Changes
Other Study ID Numbers: DXV407
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 31, 2007
Last Verified: October 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