Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2025-09-10
2026-03-31
Brief Summary
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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
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort A
Undergoing a standard of care CCTA
GSI Cardiac Scan
The investigational GSI Cardiac scan will take place immediately ("back-to-back acquisition") following the single energy, non-GSI CCTA. The GSI Cardiac scan takes around 1 minute.
A subset of Cohort B's participants who are eligible due to a history of heart attack will have the investigational GSI Cardiac scan 10-15 minutes after the end of the CCTA scan.
Standard of Care CCTA
The standard of care scan will be a single-energy, non-GSI CCTA. Any pre-contrast screening (such as kidney function or pregnancy testing) will follow the site's standard operating procedures. The administration of contrast media (either IV or oral) and any cardiac medications used to control heart rate will be prescribed per the site's standard operating procedures. All contrast and cardiac medications will be FDA approved and used in accordance with its approval.
Cohort B
Known history of heart attack (myocardial infarction) or undergoing a standard of care cardiac catheterization due to known disease
GSI Cardiac Scan
The investigational GSI Cardiac scan will take place immediately ("back-to-back acquisition") following the single energy, non-GSI CCTA. The GSI Cardiac scan takes around 1 minute.
A subset of Cohort B's participants who are eligible due to a history of heart attack will have the investigational GSI Cardiac scan 10-15 minutes after the end of the CCTA scan.
Research CCTA
The research scan will be a single-energy, non-GSI CCTA. Any pre-contrast screening (such as kidney function or pregnancy testing) will follow the site's standard operating procedures. The administration of contrast media (either IV or oral) and any cardiac medications used to control heart rate will be prescribed per the site's standard operating procedures. All contrast and cardiac medications will be FDA approved and used in accordance with its approval.
Interventions
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GSI Cardiac Scan
The investigational GSI Cardiac scan will take place immediately ("back-to-back acquisition") following the single energy, non-GSI CCTA. The GSI Cardiac scan takes around 1 minute.
A subset of Cohort B's participants who are eligible due to a history of heart attack will have the investigational GSI Cardiac scan 10-15 minutes after the end of the CCTA scan.
Standard of Care CCTA
The standard of care scan will be a single-energy, non-GSI CCTA. Any pre-contrast screening (such as kidney function or pregnancy testing) will follow the site's standard operating procedures. The administration of contrast media (either IV or oral) and any cardiac medications used to control heart rate will be prescribed per the site's standard operating procedures. All contrast and cardiac medications will be FDA approved and used in accordance with its approval.
Research CCTA
The research scan will be a single-energy, non-GSI CCTA. Any pre-contrast screening (such as kidney function or pregnancy testing) will follow the site's standard operating procedures. The administration of contrast media (either IV or oral) and any cardiac medications used to control heart rate will be prescribed per the site's standard operating procedures. All contrast and cardiac medications will be FDA approved and used in accordance with its approval.
Eligibility Criteria
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Inclusion 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
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.)
18 Years
ALL
No
Sponsors
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University of Washington
OTHER
GE Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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Brian Thomsen
Role: STUDY_DIRECTOR
GE Healthcare
Locations
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University of Washington
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Hamid Chalian, MD
Role: primary
Other Identifiers
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SA-000042
Identifier Type: -
Identifier Source: org_study_id