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| Name | Class |
|---|---|
| GE Healthcare | INDUSTRY |
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To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCTA Patient |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy | 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. | 30 days |
| Diagnostic Interpretability | 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. | 30 days |
| Image quality | 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. | 30 day |
| Measure | Description | Time Frame |
|---|---|---|
| Upper threshold of heart rate | To determine the upper threshold of heart rate below which CCTA with SSF is most effective. | 1 day |
| incremental & additive value | To determine the incremental & additive value of SSF to conventional CCTA for diagnostic accuracy / diagnostic interpretability / image quality. |
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Inclusion Criteria:
Exclusion Criteria:
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Consenting adult patients ≥18 years of age, Suspected but without known prior history of CAD, Not actively taking heart rate lowering agents at least 48 hours prior to study (e.g., AV nodal blockers such as beta blockers, calcium channel blockers or digoxin)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MDDX | San Francisco | California | 94104 | United States | ||
| Walter Reed Medical Center |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| 1 day |
| Bethesda |
| Maryland |
| United States |
| Midwest Cardiology Associates | Independence | Missouri | United States |
| Diagnostico Maipu | San Isidro | Argentina |
| University of British Columbia | Vancouver | British Columbia | V6T 1Z4 | Canada |
| FACTS | Hyderabad | India |
| Centro Cardiologico Monzino | Monzino | Italy |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |