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GSI Cardiac on Revolution Apex - US

GSI Cardiac on Revolution Apex - US

Recruiting
18 years and older
All
Phase N/A

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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:

  1. Participants scheduled to undergo a Coronary CT Angiography (CCTA) as part of their standard of care
  2. 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.)

Study details
    Coronary Computed Tomographic Angiography
    Myocardial Infarction (MI)
    Cardiac Catheterization

NCT06702917

GE Healthcare

31 January 2026

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FAQs

Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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