Dual Energy Cardiac CT Data Collection and Evaluation

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05171764
• Other study ID #: 219693723
• Status: Completed
• Start date: November 14, 2022
• Est. completion date: October 13, 2023

Study information

• Verified date: December 2023
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 Withdrawn or discontinued subjects who are enrolled and received the investigational scan, may be replaced.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 13, 2023
• Est. primary completion date: October 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Device:
• Additional 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.

Locations

Country	Name	City	State
Switzerland	Zürich University Hospital	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
GE Healthcare	University Hospital, Zürich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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