GSI Cardiac on Revolution Apex - US

Summary

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.

Conditions

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

Interventions

DEVICE

GSI Cardiac Scan

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.

OTHER

Standard of Care CCTA

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.

OTHER

Research CCTA

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.

Sponsors & Collaborators

• University of Washington

  collaborator OTHER

• GE Healthcare

  lead INDUSTRY

Principal Investigators

• Brian Thomsen · GE Healthcare

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-10

Primary Completion

2026-06-30

Completion

2026-06-30

FDA Device

Yes

Countries

• United States

Study Locations