Dual Energy Cardiac CT Data Collection and Evaluation

NCT ID: NCT05171764

Last Updated: 2023-12-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-14
• Study Completion Date: 2023-10-13

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 Withdrawn or discontinued subjects who are enrolled and received the investigational scan, may be replaced.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

Conditions

Cardiovascular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Additional Gemstone Spectral Imaging (GSI) cardiac scan

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Zürich

OTHER

Sponsor Role: collaborator

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa Challman

Role: STUDY_DIRECTOR

GE Healthcare

Locations

Zürich University Hospital

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

219693723

Identifier Type: -

Identifier Source: org_study_id