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

This study has been completed.
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00209404
First received: August 18, 2005
Last updated: October 30, 2007
Last verified: October 2007
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209404

Locations
France
Amersham Health S.A.
Velizy Cedex, France, 78457
Sponsors and Collaborators
GE Healthcare
Investigators
Study Director: Jean-Paul Antonini GE Healthcare
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00209404     History of Changes
Other Study ID Numbers: DXV407
Study First Received: August 18, 2005
Last Updated: October 30, 2007
Health Authority: France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Spain: Ministry of Health and Consumption

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Iodixanol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014