Monocentric Observational Trial for Florbetaben PET/MRI Hybrid Imaging in Patients With Cardiac Amyloidosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Occurence of MACE
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 40 years
- •proven Amyloidosis (ATTR or AL)
- •Women: negative pregnancy test less than weeks prior imaging.
排除标准
- •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
结局指标
主要结局
Occurence of MACE
时间窗: 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.
次要结局
- Hazard Ratios for visual PET positivity(36 Months)
- MACE free survival by optimal tracer retention index for MACE(36 Months)
- MACE free survival by optimal SUV threshold for MACE(36 Months)
- MACE free survival by optimal retention index for AL-Amyloidosis(36 Months)
- Hazard Ratios for SUV(36 Months)
- MACE free survival by optimal PET based threshold for AL-Amyloidosis(36 Months)
- Hazard Ratios for retention index(36 Months)
- Hazard Ratios for tracer washout(36 Months)