GSI Cardiac on Revolution Apex - US

NCT06702917 | Recruiting FDA Device

• 1 other identifier: SA-000042
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months

Secondary Outcomes (1)

• Safety Assessment

  12 months

Study Arms (2)

Cohort A

Undergoing a standard of care CCTA

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

Cohort B

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

Device: GSI Cardiac Scan; Other: Research CCTA

Interventions

GSI Cardiac Scan DEVICE

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.

Cohort A; Cohort B

Standard of Care CCTA OTHER

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.

Cohort A

Research CCTA OTHER

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.

Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• GE Healthcare: lead
• University of Washington: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Brian Thomsen

  GE Healthcare

  STUDY DIRECTOR

Central Study Contacts

Melissa Challman

CONTACT

8582213007; melissa.challman@gehealthcare.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 25, 2024
• Study Start: September 10, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)