GSI Cardiac on Revolution Apex - US (NCT06702917) | Clinical Trial Compass
RecruitingNot Applicable
GSI Cardiac on Revolution Apex - US
United States50 participantsStarted 2025-09-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Who are ā„18 years of age;
ā. Able to sign and date the informed consent form; AND,
ā. Cohort A: Undergoing a scheduled clinically indicated CCTA; OR,
ā. Cohort B: Known history of myocardial infarction or undergoing a clinically indicated cardiac catheterization due to known pathology.
Exclusion criteria
ā. Who are pregnant or lactating;
ā. Who were previously enrolled in this study;
ā. Anyone with known or suspected allergy to iodinated contrast agents;
ā. Anyone with known or suspected renal insufficiency as determined by site medical personnel;
ā. Who are in need of urgent or emergent care;
ā. 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;