Coronary Computed Tomographic AngiographyNCT06702917
GSI Cardiac on Revolution Apex - US
An observational study of Coronary Computed Tomographic Angiography and Myocardial Infarction (MI), run by GE Healthcare at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Computed Tomographic Angiography, Myocardial Infarction (MI), Cardiac Catheterization
- What is being tested?
- GSI Cardiac Scan and Research CCTA
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2025to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subject population will consist of adults that are 18-years of age or older, and who are undergoing either a scheduled CCTA, a scheduled cardiac catheterization due to known history of pathology or is a patient with known history of myocardial infarction.
Who may be able to join
- Subjects may be included in this study if they meet the following criteria:
- Who are ≥18 years of age;
- Able to sign and date the informed consent form; AND,
- Cohort A: Undergoing a scheduled clinically indicated CCTA; OR,
- Cohort B: Known history of myocardial infarction or undergoing a clinically indicated cardiac catheterization due to known pathology.
Who cannot join
- Subjects may be excluded from participating in study if they meet any of the following criteria:
- Who are pregnant or lactating;
- Who were previously enrolled in this study;
- Anyone with known or suspected allergy to iodinated contrast agents;
- Anyone with known or suspected renal insufficiency as determined by site medical personnel;
- Who are in need of urgent or emergent care;
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- 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;
- Who are unwilling to have GEHC personnel present for the CT exam; AND,
- Cohort A: Undergoing a scheduled clinically indicated CCTA for anatomy assessment (aberrant origin, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wide Coverage GSI Cardiac Data Collection
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:
Read more
- Participants scheduled to undergo a Coronary CT Angiography (CCTA) as part of their standard of care
- 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.
- Conditions
- Coronary Computed Tomographic Angiography, Myocardial Infarction (MI), Cardiac Catheterization
- Being tested
- GSI Cardiac Scan, Standard of Care CCTA, Research CCTA
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSI Cardiac ScanDevice
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 CCTAOther
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 CCTAOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Undergoing a standard of care CCTA Receives: Device: GSI Cardiac Scan; Other: Standard of Care CCTA | |
| Cohort B | Known history of heart attack (myocardial infarction) or undergoing a standard of care cardiac catheterization due to known disease Receives: Device: GSI Cardiac Scan; Other: Research CCTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluable GSI Cardiac Raw Scans
Number of participants whose GSI Cardiac scan is deemed evaluable (i.e., no issues with participant motion or contrast administration and/or timing).
Measured: 12 months
Secondary outcomes (1)
Safety Assessment
Number of Adverse Events and/or Serious Adverse Events reported.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start10 Sep 2025
- Primary completion3 Apr 2026
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Computed Tomographic AngiographyStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Washington
- Responsible party
- Sponsor
- Investigators
- Brian Thomsen, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702917
- Sponsor's protocol ID
- SA-000042
- Status last verified
- Jul 2026
- First submitted
- 22 Nov 2024
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wide Coverage GSI Cardiac Data Collection
- ClinicalTrials.gov ID
- NCT06702917
- Acronym / sponsor ID
- SA-000042
- Conditions
- Coronary Computed Tomographic Angiography, Myocardial Infarction (MI), Cardiac Catheterization
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- University of Washington
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 3 Apr 2026 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Participants scheduled to undergo a Coronary CT Angiography (CCTA) as part of their standard of care
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Device: GSI Cardiac Scan, Other: Standard of Care CCTAUndergoing a standard of care CCTA |
| Cohort B | – | Device: GSI Cardiac Scan, Other: Research CCTAKnown history of heart attack (myocardial infarction) or undergoing a standard of care cardiac catheterization due to known disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subject population will consist of adults that are 18-years of age or older, and who are undergoing either a scheduled CCTA, a scheduled cardiac catheterization due to known history of pathology or is a patient with known history of myocardial infarction.
Key inclusion criteria (5 listed)
- Who are ≥18 years of age;
- Able to sign and date the informed consent form; AND,
- Cohort A: Undergoing a scheduled clinically indicated CCTA; OR,
- Cohort B: Known history of myocardial infarction or undergoing a clinically indicated cardiac catheterization due to known pathology.
Key exclusion criteria (9 listed)
- Subjects may be excluded from participating in study if they meet any of the following criteria:
- Who are pregnant or lactating;
- Who were previously enrolled in this study;
- Anyone with known or suspected allergy to iodinated contrast agents;
- Anyone with known or suspected renal insufficiency as determined by site medical personnel;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSI Cardiac ScanThe 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. | Device | Cohort A, Cohort B |
| Standard of Care CCTAThe 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. | Other | Cohort A |
| Research CCTAThe 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. | Other | Cohort B |
Primary outcome
Evaluable GSI Cardiac Raw Scans
Time frame: 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).
1 secondary outcome
Safety Assessment
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Thomsen study director
GE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Computed Tomographic Angiography and Myocardial Infarction (MI), run by GE Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluable GSI Cardiac Raw Scans (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.