Dual Energy Cardiac CT Data Collection and Evaluation

NCT05171764 | Completed FDA Device

• 1 other identifier: 219693723
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation- Likert Scale

  through study completion, an average of 1 year

Study Arms (1)

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

Interventions

Additional Gemstone Spectral Imaging (GSI) cardiac scan 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.

Coronary CTA

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients \> 50 years old undergoing routine cardiac CT imaging exam;
• Patients that within last 12 months did not undergo medical procedures involving ionizing radiation;
• Signed informed consent.

You may not qualify if:

• Contradictions to contrast;
• Contraindications for beta blocker;
• BMI \>30;
• High heart rate ≥75 BPM;
• Atrial Fibrillation;
• Arrythmia or irregular heartbeats;
• Pregnant women;
• Patients lacking capacity in providing informed consent
• Patients who did participate in prior research studies with ionizing radiation in the last 12 months.

Sponsors & Collaborators

• GE Healthcare: lead
• University Hospital, Zürich: collaborator

Study Sites (1)

Zürich University Hospital

Zurich, Switzerland

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Melissa Challman

  GE Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 29, 2021
• Study Start: November 14, 2022
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Locations

CH (1)