Cardiac Amyloidosis
Conditions
Keywords
PET/MRI, Florbetaben
Brief summary
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).
Detailed description
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.
Interventions
None listed
Sponsors
University Hospital, Essen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 40 years * proven Amyloidosis (ATTR or AL) * Women: negative pregnancy test less than weeks prior imaging.
Exclusion criteria
* Patients receiving amyloidosis-specific treatment prior study inclusion. * Patients participating in other clinical trails for treatment of Amyloidosis. * Pregnancy * Contraindiactions for MRI (eGFR\<30ml/min/1.73m2; gadolinium allergy; metallic implants or device not suited for 3T MRI). * inability of consent * Refusal of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of MACE | 36 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACE free survival by optimal SUV threshold for MACE | 36 Months | MACE free survival by optimal standardized uptake value (SUV), threshold defined by ROC analysis for prediction of MACE. |
| MACE free survival by optimal retention index for AL-Amyloidosis | 36 Months | MACE free survival by optimal SUV, threshold defined by ROC analysis for prediction of AL-Amyloidosis. |
| MACE free survival by optimal PET based threshold for AL-Amyloidosis | 36 Months | MACE free survival by optimal tracer retention index (RI) defined by ROC analysis for prediction of AL-Amyloidosis. |
| MACE free survival by optimal tracer retention index for MACE | 36 Months | MACE free survival by optimal tracer retention index (RI), threshold defined by ROC analysis for prediction of MACE. |
| Hazard Ratios for retention index | 36 Months | Hazard Ratios for tracer retention index by univariate regression analysis |
| Hazard Ratios for tracer washout | 36 Months | Hazard Ratios for tracer washout by univariate regression analysis |
| Hazard Ratios for visual PET positivity | 36 Months | Hazard Ratios for visual PET positivity defined by clear higher-than-background tracer uptake at 40-60 min post. injection. |
| Hazard Ratios for SUV | 36 Months | Hazard Ratios for SUV PET parameters by univariate regression analysis |
Countries
Germany
Contacts
Primary ContactDavid Kersting, MD, PhD
Backup ContactLukas Kessler, MD
Outcome results
None listed