GSI Cardiac on Revolution Apex - US

Part of paid clinical trials in Seattle, Washington.

Sponsor
GE Healthcare
Study ID
NCT06702917
Status
Recruiting
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Conditions

  • Cardiac Catheterization
  • Coronary Computed Tomographic Angiography
  • Myocardial Infarction (MI)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GSI Cardiac Scan — DEVICE
    The investigational GSI Cardiac scan will take place immediately ("back-to-back acquisition") following the single energy, non-GSI CCTA. The GSI Cardiac scan takes around 1 minute. A subset of Cohort B's participants who are eligible due to a history of heart attack will have the investigational GSI Cardiac scan 10-15 minutes after the end of the CCTA scan.
  • Standard of Care CCTA — OTHER
    The standard of care scan will be a single-energy, non-GSI CCTA. Any pre-contrast screening (such as kidney function or pregnancy testing) will follow the site's standard operating procedures. The administration of contrast media (either IV or oral) and any cardiac medications used to control heart rate will be prescribed per the site's standard operating procedures. All contrast and cardiac medications will be FDA approved and used in accordance with its approval.
  • Research CCTA — OTHER
    The research scan will be a single-energy, non-GSI CCTA. Any pre-contrast screening (such as kidney function or pregnancy testing) will follow the site's standard operating procedures. The administration of contrast media (either IV or oral) and any cardiac medications used to control heart rate will be prescribed per the site's standard operating procedures. All contrast and cardiac medications will be FDA approved and used in accordance with its approval.

Study Details

The goal of this clinical data collection study is to collect raw CT scan data using a new GSI Cardiac mode on GE HealthCare's Revolution Apex CT system. Two groups of participants will be enrolled: A) Participants scheduled to undergo a Coronary CT Angiography (CCTA) as part of their standard of care B) Participants scheduled to undergo a cardiac catheterization or have a history of heart attack Participants in Group A will: -Have a standard of care CCTA immediately followed by a research GSI Cardiac scan Participants in Group B will: -Have a research CCTA immediately followed by a research GSI Cardiac scan Both groups will be in the study for approximately 1 day. There are no follow-up visits after the day of scan.

Key Dates

Start date
Sep 10, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Cohort A
    Undergoing a standard of care CCTA
  • Arm: Cohort B
    Known history of heart attack (myocardial infarction) or undergoing a standard of care cardiac catheterization due to known disease

Primary Outcome Measure

Evaluable GSI Cardiac Raw Scans [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98195
Hamid Chalian, MD
[email protected]
646-707-4369
Hamid Chalian, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Washington· Seattle, WA

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