EUCTR2015-005384-16-IT进行中（未招募）1 期
A prospective single-arm, monocentric, phase-II explorative study on evaluation of diagnostic use of the PET tracer (18F)-florbetaben (Neuraceq®) in patient with patient with suspected cardiac amyloidosis - FLORAMICAR
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age>20 years, high clinical suspicion of cardiac amyloidosis based on cardiac examination, biomarkers (Nt-proBNP, HS-TnT, immunoglobulin light chains in serum and urine, plasma protein electrophoresis and serum free light chains), baseline ECG, baseline echocardiography, cardiac MRI, histological evidence of amyloid in periumbelical fat (Congo red stain).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Pregnancy checked by plasma beta-HCG or breast feeding, known ischemic heart disease, hypertrophic cardiomyopathy, storage diseases or other known causes of left ventricule hypertrophy or pseudohypertrophy, hypersensitivity to the active substance or to any of the excipients of the study drug Neuraceq®, renal failure, liver failure.
研究者
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