GSI Cardiac on Revolution Apex - US

Not yet recruiting

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

• Registration Number: NCT06702917
• Lead Sponsor: GE Healthcare

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-22
• Study First Submitted QC: 2024-11-22
• Last Update Submitted: 2024-11-22
• Study First Posted: 2024-11-25
• Last Update Posted: 2024-11-25
• Study Start: 2025-01
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluable GSI Cardiac Raw Scans	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 Outcome Measures

Name	Time	Method
Safety Assessment	12 months	Number of Adverse Events and/or Serious Adverse Events reported.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States