Overview
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:
- Participants scheduled to undergo a Coronary CT Angiography (CCTA) as part of their standard of care
- 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.
Eligibility
Inclusion Criteria:
Subjects may be included in this study if they meet the following criteria:
- 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.
Exclusion Criteria:
Subjects may be excluded from participating in study if they meet any of the following criteria:
- 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;
- Who are in need of urgent or emergent care;
- Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject;
- Who are unwilling to have GEHC personnel present for the CT exam; AND,
- Cohort A: Undergoing a scheduled clinically indicated CCTA for anatomy assessment (aberrant origin, etc.)