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Lack of funding to continue.
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The purpose of this study is to understand how simultaneous PET/MR acquisition can provide novel qualitative and quantitative biomarkers to guide clinical intervention and predict prognosis of patients with cardiovascular disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac patients receiving PET/MR | Other | PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET-MRI | Device | PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Quality PET and PET/MR Images With Regional Myocardial Uptake of 18F-Fluorodeoxyglucose (FDG) in Participants Without Overt Diagnosis of Ischemic Coronary Artery Disease. | Visual analysis of collected image pairs. Evaluated by experienced imaging providers as yes or no. | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen G Ordovas, MD,MAS | Assistent Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF University of California in San Francisco | San Francisco | California | 94107 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cardiac Patients Receiving PET/MR | PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour. PET-MRI: PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cardiac Patients Receiving PET/MR | PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour. PET-MRI: PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Quality PET and PET/MR Images With Regional Myocardial Uptake of 18F-Fluorodeoxyglucose (FDG) in Participants Without Overt Diagnosis of Ischemic Coronary Artery Disease. | Visual analysis of collected image pairs. Evaluated by experienced imaging providers as yes or no. | Posted | Number | quality image | 2 hours |
|
|
One year
Imaging agent FDG has demonstrated a minimal risk, with no allergy or other local or systemic side effects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cardiac Patients Receiving PET/MR | PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour. PET-MRI: PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| miguel hernandez pampaloni | University of California San Francisco | 4153531886 | miguel.pampaloni@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 12, 2016 | Mar 16, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 2 |
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| 2 |
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| 2 |
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