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.

Eligibility

Inclusion Criteria:

Subjects may be included in this study if they meet the following criteria:

1. Who are ≥18 years of age;
2. Able to sign and date the informed consent form; AND,
3. Cohort A: Undergoing a scheduled clinically indicated CCTA; OR,
4. 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:

1. Who are pregnant or lactating;
2. Who were previously enrolled in this study;
3. Anyone with known or suspected allergy to iodinated contrast agents;
4. Anyone with known or suspected renal insufficiency as determined by site medical personnel;
5. Who are in need of urgent or emergent care;
6. 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;
7. Who are unwilling to have GEHC personnel present for the CT exam; AND,
8. Cohort A: Undergoing a scheduled clinically indicated CCTA for anatomy assessment (aberrant origin, etc.)

Conditions4

Locations1 site

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