Dual Energy Cardiac CT Data Collection and Evaluation

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Device: Additional Gemstone Spectral Imaging (GSI) cardiac scan

• Registration Number: NCT05171764
• Lead Sponsor: GE Healthcare

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 Withdrawn or discontinued subjects who are enrolled and received the investigational scan, may be replaced.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

Study Timeline

• Study First Submitted: 2021-11-25
• Study First Submitted QC: 2021-12-10
• Study First Posted: 2021-12-29
• Study Start: 2022-11-14
• Primary Completion: 2023-10-13
• Study Completion: 2023-10-13
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary CTA	Additional Gemstone Spectral Imaging (GSI) cardiac scan	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Zürich University Hospital; 🇨🇭 Zürich, Switzerland