跳至主要内容
临床试验/NCT03040427
NCT03040427终止4 期

The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
12
试验地点
1
主要终点
Quantitative Myocardial F18-florbetapir Uptake

研究概览

简要总结

The investigators postulate that F-18 florbetapir will show improved detection of cardiac amyloidosis over conventional non-invasive imaging techniques, particularly in early disease.

详细描述

F-18 florbetapir is currently used for the early detection of brain amyloid (Alzheimer's disease). The hypothesis is that F-18 florbetapir will detect amyloid deposition in myocardium prior to current non-invasive diagnostic measures, particular electrocardiography with strain and technetium pyrophosphate scintigraphy. The investigators intend to use F-18 florbetapir and assess its correlation between standard non-invasive diagnostic modalities.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with extra-cardiac biopsy-proven AL or ATTR amyloidosis
  • Patients with a ratio of affected to unaffected free light chains >5 or free light chain difference of >50

排除标准

  • Echocardiographic evidence of cardiac amyloidosis with septal and posterior wall thickness ≥ 13mm
  • Contraindication to florbetapir or its components
  • Refusal to participate in the study

研究组 & 干预措施

AL or TTR type amyloidosis

Experimental

The participants will undergo F-18 florbetapir PET scan.

干预措施: F-18 florbetapir (Drug)

结局指标

主要结局

Quantitative Myocardial F18-florbetapir Uptake

时间窗: at the time of the PET scan

Number of participants with quantitative F18-florbetapir uptake above previously defined control values

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验