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Clinical Trial Summary

To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy.


Clinical Trial Description

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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01856504
Study type Observational [Patient Registry]
Source MDDX LLC
Contact
Status Completed
Phase N/A
Start date May 2013
Completion date March 2015

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