Actively Recruiting
Wide Coverage GSI Cardiac Data Collection Using Revolution Apex CT System
Led by GE Healthcare · Updated on 2026-04-27
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
G
GE Healthcare
Lead Sponsor
U
University of Washington
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are collecting raw CT scan data using a new GSI Cardiac mode on GE HealthCare's Revolution Apex CT system. The study involves two groups: participants scheduled for standard Coronary CT Angiography (CCTA) and those with a history of heart attack or undergoing cardiac catheterization. The goal is to evaluate the GSI Cardiac scan data and assess safety over a 12-month period. Participants in the first group will have their standard CCTA scan followed immediately by the investigational GSI Cardiac scan, which takes about one minute. Those in the second group will undergo a research CCTA followed by the GSI Cardiac scan, with some having the GSI scan 10-15 minutes after the CCTA. Both groups complete these scans in one day, with no follow-up visits afterward. During the study day, participants will have scans performed and any necessary pre-contrast screenings such as kidney function or pregnancy tests will follow standard practices. Contrast media and cardiac medications will be used as needed per site procedures. Researchers will collect and evaluate the raw GSI Cardiac scan data and monitor safety outcomes for up to 12 months.
CONDITIONS
Brief Title
GSI Cardiac on Revolution Apex - US
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able to sign and date the informed consent form
- Undergoing a scheduled clinically indicated Coronary CT Angiography (CCTA) (Cohort A)
- Known history of myocardial infarction or undergoing a clinically indicated cardiac catheterization due to known disease (Cohort B)
You will not qualify if you...
- Pregnant or lactating individuals
- Previously enrolled in this study
- Known or suspected allergy to iodinated contrast agents
- Known or suspected renal insufficiency as determined by site medical personnel
- In need of urgent or emergent care
- Any condition that would interfere with evaluation results or pose a health hazard as judged by the investigator
- Unwillingness to have GE Healthcare personnel present during the CT exam
- Cohort A participants undergoing CCTA for anatomy assessment (such as aberrant origin)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo investigational GSI Cardiac scans and standard of care cardiac imaging procedures as part of the study assessments.
1 visit (in-person)
Duration - 12 months
Participants are monitored for safety and outcomes related to the cardiac imaging procedures over 12 months.
Follow-up visits as per clinical indication
Trial Site Locations
Total: 1 location
1
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
M
Melissa Challman
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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