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Exploration of prognostic parameters in 18F-Florbetaben PET/MRI in patients with cardiac amyloidosis. The clinical endpoints are defined as occurence of major adverse cardiac events (MACE) in amyloidosis patients. Additionally, MACE outcome stratified by PET parameters will be evaluated and individual parameters of the imaging techniques will be compared to each other (PET, MRI or echocardiography).
The aim of the study is to investigate the value of hybdrid imaging using 18F-Florbetaben PET/MRI for detecting prognostically relevant disease markers in patients with cardiac amyloidosis. The clinical endpoints are defined as occurence of major adverse cardiac events (e.g. hospitalizations due to heart failure, cardiovascular mortality, implantation of cardioverters etc.) in PET positive and negative patients.
Additionally, MACE outcome stratified by PET parameters will be evaluated and individual parameters of the imaging techniques will be compared to each other. CMR imaging will focused on LGE presence, ECV, native T1 mapping and echocardiography on commonly used markers includiging EF, Strain, E/e' and other functional parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amyloidosis | Oberservation of patients with proven cardiac amyloidosis and Florbetaben PET/MRI as part of diagnostic work up |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurence of MACE | Occurence of MACE, MACE defined as All-cause of Death or Hospitalization due to heart failure, implantation of a cardioverter defibrillator or other urgent cardiovascular intervention. | 36 Months |
| Measure | Description | Time Frame |
|---|---|---|
| MACE free survival by optimal tracer retention index for MACE | MACE free survival by optimal tracer retention index (RI), threshold defined by ROC analysis for prediction of MACE. | 36 Months |
| MACE free survival by optimal SUV threshold for MACE |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with proven amyloidosis with no competing amyloidosis treatments, willing and capable of undergoing Florbetaben PET/MRI.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Kersting, MD, PhD | Contact | +492017232073 | david.kersting@uk-essen.de | |
| Lukas Kessler, MD | Contact | +492017232073 | lukas.kessler@uk-essen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nuclear medicine, University Hospital Essen | Recruiting | Essen | North Rhine-Westphalia | 45147 | Germany |
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| ID | Term |
|---|---|
| D028227 | Amyloid Neuropathies, Familial |
| ID | Term |
|---|---|
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D009422 | Nervous System Diseases |
| D017772 | Amyloid Neuropathies |
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MACE free survival by optimal standardized uptake value (SUV), threshold defined by ROC analysis for prediction of MACE.
| 36 Months |
| MACE free survival by optimal retention index for AL-Amyloidosis | MACE free survival by optimal SUV, threshold defined by ROC analysis for prediction of AL-Amyloidosis. | 36 Months |
| MACE free survival by optimal PET based threshold for AL-Amyloidosis | MACE free survival by optimal tracer retention index (RI) defined by ROC analysis for prediction of AL-Amyloidosis. | 36 Months |
| Hazard Ratios for SUV | Hazard Ratios for SUV PET parameters by univariate regression analysis | 36 Months |
| Hazard Ratios for retention index | Hazard Ratios for tracer retention index by univariate regression analysis | 36 Months |
| Hazard Ratios for tracer washout | Hazard Ratios for tracer washout by univariate regression analysis | 36 Months |
| Hazard Ratios for visual PET positivity | Hazard Ratios for visual PET positivity defined by clear higher-than-background tracer uptake at 40-60 min post. injection. | 36 Months |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D028226 | Amyloidosis, Familial |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |