Cardiac Disease
Conditions
Keywords
Positron Emission Tomography-Magnetic Resonance Imaging, Cardiac Disease
Brief summary
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.
Detailed description
* To compare regional myocardial uptake of FDG on images obtained on a standard PET camera with the new PET/MR camera, in patients with coronary artery disease. * To compare viability maps obtained with cardiac MR images and FDG-PET for delineation of myocardial infarct core and border zone, in patients with coronary artery disease. * To correlate MRI myocardial strain with relative myocardial FDG uptake in patients with a previous myocardial infarction. * To interrogate if simultaneous acquisition of cardiac PET and viability cardiac MR differ from acquisitions obtained independently, with special focus on attenuation correction methods * To combined MRI scar map with FDG-PET uptake in patients with cardiac sarcoidosis and myocarditis. * To correlate morphologic characteristics of atherosclerotic disease in the thoracic and abdominal aorta with FDG uptake and ferumoxytol enhancement, as a marker of inflammation. * To evaluate cardiac strain and myocardial scar burden in obese patients with and without diabetes.
Interventions
DEVICEPET-MRI
PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour.
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with ischemic and non-ischemic cardiac disease referred for cardiac PET for viability imaging.
Exclusion criteria
* Contraindications for MRI, including cardiac pacemaker, claustrophobia, retained metallic foreign body, cochlear implant, Aneurysm clip in the brain, pregnancy and eGFR less than 45%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 2 hours | Visual analysis of collected image pairs. Evaluated by experienced imaging providers as yes or no. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Cardiac Patients Receiving PET/MR |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 48 years STANDARD_DEVIATION 5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
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.
Time frame: 2 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardiac Patients Receiving PET/MR | 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. | 2 quality image |