Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06702917

GSI Cardiac on Revolution Apex - US

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Coronary Computed Tomographic Angiography Cardiac Catheterization Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Infarction (MI) Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Washington

Seattle, Washington, 98195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.)

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Evaluable GSI Cardiac Raw Scans

    Time frame: 12 months

    Number of participants whose GSI Cardiac scan is deemed evaluable (i.e., no issues with participant motion or contrast administration and/or timing).

Secondary outcomes

  1. Safety Assessment

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

  • University of Washington

Registry information

Official study title

Wide Coverage GSI Cardiac Data Collection

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2024
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.