GSI Cardiac on Revolution Apex - US

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGE Healthcare

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • GSI Cardiac Scan
  • Standard of Care CCTA
  • Research CCTA

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

GE Healthcare

Lead sponsor

University of Washington

Collaborator