Comparison of Isovue 370 vs. Standard Protocol in Coronary Computed Tomographic Angiography (CTA)
Comparison of the Use of High Iodine Concentration Contrast Material (Isovue 370) vs. Standard Protocol in Coronary Computed Tomographic Angiography (CTA)
1 other identifier
interventional
35
0 countries
N/A
Brief Summary
Computed Tomography Angiogram (CTA) scans are performed routinely to look at the vessels in the body as an alternative to directly injecting contrast into the vessels and taking pictures. Different types of intravenous (into the vein, IV) contrast are available to fill the vessels and make them easier to see. The purpose of the study is to determine the best type of contrast for this scan.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2008
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 12, 2014
CompletedFirst Posted
Study publicly available on registry
June 24, 2014
CompletedResults Posted
Study results publicly available
August 15, 2014
CompletedAugust 15, 2014
July 1, 2014
2.7 years
June 12, 2014
July 28, 2014
July 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Contrast to Noise Ratio
Contrast-to-noise ratios (CNRs) were calculated as follows: CNR = (vascular attenuation - myocardium attenuation) / SD of mean noise attenuation.
during scan, approximately 3 hours
Image Quality
Depiction of Branch Vessels - coronary branch depiction was performed as consensus decisions of two blinded radiologists. Criteria used was abscence or presence of vessels.
during scan, approximately 3 hours
Motion Artifact
The outcome will be measured by individual scores. The scores from multiple readers will be averaged.
during scan, approximately 3 hours
Attenuation of the Ascending Aorta and Coronary Arteries
The investigator will measure the length of visualized coronary artery for the left anterior descending, left circumflex and right coronary arteries as a way of quantifying visualization of distal coronary segments.
during scan, approximately 3 hours
Study Arms (2)
Isovue 370
ACTIVE COMPARATORIsovue 370 is a contrast agent with increased iodine concentration.
Visipaque 320
ACTIVE COMPARATORStandard protocol is Visipaque 320.
Interventions
Eligibility Criteria
You may qualify if:
- adult patients who are referred for coronary CTA for suspected or known coronary artery disease
You may not qualify if:
- creatinine greater than 2.0
- allergy to contrast media
- patients under the age of 18
- women who are pregnant or breast feeding
- patients with cardiac arrhythmia will also be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Daniel T Boll, MD
- Organization
- Duke University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel T Boll, MD
Duke University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2014
First Posted
June 24, 2014
Study Start
April 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
August 15, 2014
Results First Posted
August 15, 2014
Record last verified: 2014-07