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.
Who are ≥18 years of age;
Able to sign and date the informed consent form; AND,
Cohort A: Undergoing a scheduled clinically indicated CCTA; OR,
Cohort B: Known history of myocardial infarction or undergoing a clinically indicated cardiac catheterization due to known pathology.
Who are pregnant or lactating;
Who were previously enrolled in this study;
Anyone with known or suspected allergy to iodinated contrast agents;
Anyone with known or suspected renal insufficiency as determined by site medical personnel;
The subject population will consist of adults that are 18-years of age or older, and who are undergoing either a scheduled CCTA, a scheduled cardiac catheterization due to known history of pathology or is a patient with known history of myocardial infarction.
Cohort
Prospective
GSI Cardiac Scan
DeviceThe 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 interventionThe 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 interventionThe 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.
Evaluable GSI Cardiac Raw Scans
Number of participants whose GSI Cardiac scan is deemed evaluable (i.e., no issues with participant motion or contrast administration and/or timing).
Safety Assessment
Number of Adverse Events and/or Serious Adverse Events reported.
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GE Healthcare
Lead sponsor
University of Washington
Collaborator
