Dual Energy Cardiac CT Data Collection and Evaluation

General Electric (GE)

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Device: Additional Gemstone Spectral Imaging (GSI) cardiac scan

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05171764

219693723

Details and patient eligibility

About

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.

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 Withdrawn or discontinued subjects who are enrolled and received the investigational scan, may be replaced.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

Enrollment: 30 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

Coronary CTA

Description:

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.

Treatment:

Device: Additional Gemstone Spectral Imaging (GSI) cardiac scan