GSI Cardiac on Revolution Apex - US

Not yet recruitingOBSERVATIONAL
Enrollment

50

Participants

Timeline

Start Date

January 31, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Coronary Computed Tomographic AngiographyMyocardial 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.

Trial Locations (1)

98195

University of Washington, Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

University of Washington

OTHER

lead

GE Healthcare

INDUSTRY