GSI Cardiac on Revolution Apex - US

GE Healthcare50 enrolled

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: 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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Coronary Computed Tomographic Angiography Myocardial Infarction (MI)Cardiac Catheterization

Interventions

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.

Standard of Care CCTAOTHER

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.

Research CCTAOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.)

Outcomes

Primary Outcomes

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).

Time frame: 12 months

Secondary Outcomes

Safety Assessment

Number of Adverse Events and/or Serious Adverse Events reported.