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.
Study Type
OBSERVATIONAL
Enrollment
25
Department of Nuclear medicine, University Hospital Essen
Essen, North Rhine-Westphalia, Germany
RECRUITINGOccurence 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.
Time frame: 36 Months
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.
Time frame: 36 Months
MACE free survival by optimal SUV threshold for MACE
MACE free survival by optimal standardized uptake value (SUV), threshold defined by ROC analysis for prediction of MACE.
Time frame: 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.
Time frame: 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.
Time frame: 36 Months
Hazard Ratios for SUV
Hazard Ratios for SUV PET parameters by univariate regression analysis
Time frame: 36 Months
Hazard Ratios for retention index
Hazard Ratios for tracer retention index by univariate regression analysis
Time frame: 36 Months
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Hazard Ratios for tracer washout
Hazard Ratios for tracer washout by univariate regression analysis
Time frame: 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.
Time frame: 36 Months