Back to resultsIodixanol in Multidetector-Row Computed Tomography-Coronary Angiography (MDCT-CA)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Iodixanol 320 mg I/Ml
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring MDCT, Coronary Artery, Heart Rate, Image Quality, Diagnostic Quality
Eligibility 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.
Sites / Locations
- Amersham Health S.A.
Outcomes
Primary Outcome Measures
Change in mean heart rate
Secondary Outcome Measures
Image quality
Diagnostic quality
Overall diagnostic information
Frequency and intensity of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00209404
Brief Title
Iodixanol in Multidetector-Row Computed Tomography-Coronary Angiography (MDCT-CA)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GE Healthcare
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
MDCT, Coronary Artery, Heart Rate, Image Quality, Diagnostic Quality
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Iodixanol 320 mg I/Ml
Primary Outcome Measure Information:
Title
Change in mean heart rate
Secondary Outcome Measure Information:
Title
Image quality
Title
Diagnostic quality
Title
Overall diagnostic information
Title
Frequency and intensity of adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Paul Antonini
Organizational Affiliation
GE Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
Amersham Health S.A.
City
Velizy Cedex
ZIP/Postal Code
78457
Country
France
12. IPD Sharing Statement
Learn more about this trial
Iodixanol in Multidetector-Row Computed Tomography-Coronary Angiography (MDCT-CA)
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