Dual Energy Cardiac CT Data Collection and Evaluation

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Withdrawn or discontinued subjects who are enrolled and received the investigational scan, may be replaced.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.

Official Title
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Feasibility and Data Collection of Dual Energy Cardiac CT on a Wide Coverage System

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Device: Additional Gemstone Spectral Imaging (GSI) cardiac scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients > 50 years old undergoing routine cardiac CT imaging exam; Patients that within last 12 months did not undergo medical procedures involving ionizing radiation; Signed informed consent. Exclusion Criteria: Contradictions to contrast; Contraindications for beta blocker; BMI >30; High heart rate ≥75 BPM; Atrial Fibrillation; Arrythmia or irregular heartbeats; Pregnant women; Patients lacking capacity in providing informed consent Patients who did participate in prior research studies with ionizing radiation in the last 12 months.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronary CTA<br>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. | Device: Additional Gemstone Spectral Imaging (GSI) cardiac scan<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |