GSI Cardiac on Revolution Apex - US

Launched by GE HEALTHCARE · Nov 22, 2024

Keywords

ClinConnect Summary

This clinical trial, called the GSI Cardiac on Revolution Apex - US, is designed to gather information about a new type of CT scan called GSI Cardiac, which is being tested on GE HealthCare's Revolution Apex CT system. The aim is to see how well this new technology works for patients who need heart imaging procedures. There are two groups of participants: one group will have a standard heart scan called Coronary CT Angiography (CCTA) followed by the new GSI Cardiac scan, while the other group will have either a history of heart attack or be scheduled for a procedure called cardiac catheterization, and they will only receive the new scan.

To be eligible for this study, participants need to be at least 18 years old and able to give their consent. The first group is for those who are already scheduled for a standard CCTA, and the second group is for those with a known history of heart issues. The trial will only take about one day, with no follow-up visits required afterward. It's important to note that certain individuals, such as those who are pregnant or have specific health conditions, may not be able to participate. Overall, this study aims to improve heart imaging techniques, which could lead to better care for patients in the future.

Gender

ALL

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.)