Dual Energy Cardiac CT Data Collection and Evaluation

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Device: Additional Gemstone Spectral Imaging (GSI) cardiac scan

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 Withdrawn or discontinued subjects who are enrolled and received the investigational scan, may be replaced.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 Type: Observational
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Karwedsky; Phone Number: 262-443-7008; Email: stephanie.karwedsky@ge.com

Study Locations

• Switzerland
  • Zürich, Switzerland
    • Zurich University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GE Healthcare
• Collaborators: University Hospital, Zürich
• Investigators: Study Director: Melissa Challman, GE Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Actual): October 13, 2023
• Study Completion (Actual): October 13, 2023

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 219693723

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes