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| Name | Class |
|---|---|
| University of Washington | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Undergoing a 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSI Cardiac Scan | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment | Number of Adverse Events and/or Serious Adverse Events reported. | 12 months |
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Inclusion Criteria:
Subjects may be included in this study if they meet the following criteria:
Exclusion Criteria:
Subjects may be excluded from participating in study if they meet any of the following criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa Challman | Contact | 8582213007 | melissa.challman@gehealthcare.com |
| Name | Affiliation | Role |
|---|---|---|
| Brian Thomsen | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Recruiting | Seattle | Washington | 98195 | United States |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Standard of Care CCTA | Other | 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 | Other | 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. |
|
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |