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| Name | Class |
|---|---|
| University Hospital, Zürich | OTHER |
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This study is intended to collect clinical feasibility data using this prototype research mode for the purposes of understanding potential clinical impact, potential limitations and strengths, and to further develop the technique through development of image reconstruction and processing approaches or identification of other areas of development required.
Up to 38 subjects may be enrolled to achieve the target number of 30 evaluable subjects. Withdrawn or discontinued subjects who are enrolled and received the investigational scan, may be replaced. Subject participation will be deemed complete once the diagnostic and investigational scans are completed. A subject is considered evaluable when images and raw data from the diagnostic single energy cardiac CT scan and raw data from the investigational dual energy cardiac CT scan have been collected successfully and demonstrate a diagnostic interpretation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary CTA | After the subject undergoes the standard of care, clinically indicated cardiac CT scan for diagnostic purposes, the investigational scan using the GSI Cardiac Scan Mode will be conducted utilizing the same contrast administration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Additional Gemstone Spectral Imaging (GSI) cardiac scan | Device | After the subject undergoes the clinically prescribed cardiac Computed Tomography (CT) scan for their diagnostic purposes, the investigational Gemstone Spectral Imaging (GSI) scan will be conducted following the diagnostic CT scan utilizing the same contrast administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Collect Data | Data will be collected from the scanner for future post-processing and engineering development. There is no analysis planned at this time for the data, simply data collection. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation- Likert Scale | Complete an image evaluation using a 5 point Likert Scale (1 - Non-Diagnostic to 5 - Excellent Image Quality), done by a qualified cardiac imaging expert. | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be enrolled that will be undergoing a routine cardiac CT imaging scan. Subjects will be representative of the general population expected to undergo cardiac CT imaging as standard of care clinical practice.
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Challman | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zürich University Hospital | Zurich | Switzerland |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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