Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY (VICTORY)
|ClinicalTrials.gov Identifier: NCT01856504|
Recruitment Status : Completed
First Posted : May 17, 2013
Last Update Posted : April 3, 2015
|Condition or disease|
|Coronary Artery Disease Coronary Arteriosclerosis|
Hypothesis: Coronary CT angiography (CCTA) employing a novel intracycle motion compensation algorithm (SnapShot Freeze [SSF]) will be superior to CCTA without an intracycle motion compensation algorithm ("conventional" CCTA) for diagnostic accuracy and image quality.
Scientific Basis: Preliminary study (Leipsic, Min, Journal of Cardiovascular Computed Tomography [in press]) of coronary CT angiograms in individuals undergoing pre-procedural assessment for transcatheter aortic valve replacement (n=36) demonstrate improved image quality of CCTA using SSF compared to CCTA not using SSF. Importantly, individuals in this study did not receive heart rate slowing agents (e.g., beta blockers), and diagnostic image quality was substantially improved. While not statistically powered on a per-patient basis, per-segment diagnostic accuracy of CCTA using SSF was superior to conventional CCTA. These results are complementary to those derived from internal testing at GE Healthcare wherein phantom work has demonstrated improved diagnostic performance using SSF compared to conventional image acquisitions.
Long-term Goal/Purpose: To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy. If the aims of this study are achieved, the use of SSF for effective temporal resolution improvement may obviate (or reduce) the need for CT hardware for improved temporal resolution.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||218 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY: A Prospective Multicenter Study|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
- Diagnostic Accuracy [ Time Frame: 30 days ]To compare the per-patient, per-vessel and per-segment diagnostic accuracy of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography.
- Diagnostic Interpretability [ Time Frame: 30 days ]To compare the per-patient, per-vessel and per-segment diagnostic interpretability of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography.
- Image quality [ Time Frame: 30 day ]To compare the per-patient, per-vessel and per-segment quantitative image quality of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography.
- Upper threshold of heart rate [ Time Frame: 1 day ]To determine the upper threshold of heart rate below which CCTA with SSF is most effective.
- incremental & additive value [ Time Frame: 1 day ]To determine the incremental & additive value of SSF to conventional CCTA for diagnostic accuracy / diagnostic interpretability / image quality.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856504
|United States, California|
|San Francisco, California, United States, 94104|
|United States, Maryland|
|Walter Reed Medical Center|
|Bethesda, Maryland, United States|
|United States, Missouri|
|Midwest Cardiology Associates|
|Independence, Missouri, United States|
|San Isidro, Argentina|
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada, V6T 1Z4|
|Centro Cardiologico Monzino|