GSI Cardiac on Revolution Apex - US

General Electric (GE)

Status: Not yet enrolling

Conditions: Cardiac Catheterization; Coronary Computed Tomographic Angiography; Myocardial Infarction (MI)

Treatments: Other: Standard of Care CCTA; Other: Research CCTA; Device: GSI Cardiac Scan

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06702917

SA-000042

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

50 participants in 2 patient groups

Cohort A

Description:

Undergoing a standard of care CCTA

Treatment:

Device: GSI Cardiac Scan

Other: Standard of Care CCTA

Cohort B

Description:

Known history of heart attack (myocardial infarction) or undergoing a standard of care cardiac catheterization due to known disease

Treatment:

Other: Research CCTA

Device: GSI Cardiac Scan