GSI Cardiac mode on the GE Revolution Apex CT scanner

Wide Coverage GSI Cardiac Data Collection

This will test a new GSI Cardiac CT scan in adults having a coronary CT angiogram or in adults with a prior heart attack or undergoing cardiac catheterization.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: GE Healthcare (Industry-sponsored)
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT06702917 on ClinicalTrials.gov

What this trial studies

This observational data collection enrolls two cohorts: patients scheduled for standard-of-care Coronary CT Angiography (CCTA) and patients with prior myocardial infarction or undergoing clinically indicated cardiac catheterization. Cohort A will have their clinical CCTA immediately followed by a research GSI Cardiac scan, while Cohort B will receive a research CCTA immediately followed by a research GSI Cardiac scan. All raw CT data are acquired on the GE HealthCare Revolution Apex system to capture GSI-specific information for image and algorithm development. Participation involves a single day on-site visit with no post-scan follow-up.

Who should consider this trial

Good fit: Adults aged 18 or older who can give informed consent and are either scheduled for a clinically indicated CCTA or have a history of myocardial infarction or are scheduled for cardiac catheterization, without contraindications to iodinated contrast or significant renal insufficiency.

Not a fit: People who are pregnant or lactating, have known or suspected allergy to iodinated contrast, have renal insufficiency, need urgent care, were previously enrolled, or have other conditions the investigator finds unsafe are not eligible and would not benefit from participation.

Why it matters

Potential benefit: If successful, the collected GSI raw data could enable improved cardiac CT image processing that may enhance coronary visualization and future diagnostic tools.

How similar studies have performed: Related spectral and dual-energy CT approaches, including prior GSI work, have shown promise for improving material separation and image quality, but collection of raw GSI Cardiac data on the Revolution Apex for this purpose is relatively new.

Eligibility criteria

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.)

Where this trial is running

Seattle, Washington

• University of Washington — Seattle, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Melissa Challman

Conditions Coronary Computed Tomographic Angiography; Myocardial Infarction; Cardiac Catheterization