Cardiovascular Diseases
Conditions
Brief summary
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
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 Withdrawn or discontinued subjects who are enrolled and received the investigational scan, may be replaced.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.
Interventions
DEVICEAdditional Gemstone Spectral Imaging (GSI) cardiac scan
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.
Sponsors
University Hospital, Zürich
GE Healthcare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients \> 50 years old undergoing routine cardiac CT imaging exam; 2. Patients that within last 12 months did not undergo medical procedures involving ionizing radiation; 3. Signed informed consent.
Exclusion criteria
1. Contradictions to contrast; 2. Contraindications for beta blocker; 3. BMI \>30; 4. High heart rate ≥75 BPM; 5. Atrial Fibrillation; 6. Arrythmia or irregular heartbeats; 7. Pregnant women; 8. Patients lacking capacity in providing informed consent 9. Patients who did participate in prior research studies with ionizing radiation in the last 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collect Data | through study completion, an average of 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation- Likert Scale | through study completion, an average of 1 year | 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. |
Countries
Switzerland
Outcome results
None listed