Analysis of the Evolution of SUVmax by Quantitative Analysis Method of Bisphosphonate Scintigraphy for the Follow-up of Patients With Transthyretin Amyloidosis Treated With Tafamidis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Measurement of SUVmax by quantitative analysis by bisphosphonate scintigraphy
研究概览
简要总结
Recently, treatment with tafamidis in patients with cardiac ATTR lead to a significant reduction in mortality. The Perugini score is commonly used on planar bone scans to differentiate cardiac ATTR from other amyloidosis or normal patients but fails to evaluate amyloid burden and patient prognosis. Although semi-quantitative methods have been suggested to evaluate the amyloid burden, there a need for quantitative methods for longitudinal assessment of the disease.
详细描述
Cardiac amyloidosis is a cause of restrictive cardiomyopathy with preserved ejection fraction associated with amyloid fibrils deposits in the myocardium. Two types of amyloid commonly infiltrate the heart: immunoglobulin light-chain amyloid (AL), and transthyretin-related amyloid amyloidosis (ATTR). Cardiac imaging is currently used for the diagnosis of ATTR, including planar scintigraphy with bone seeking radiopharmaceuticals, cardiac magnetic resonance and echocardiography with global longitudinal strain assessment.Although semi-quantitative methods have been suggested to evaluate the amyloid burden, there a need for quantitative methods for longitudinal assessment of the disease.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient, male or female, over 18 years of age
- •Patient diagnosed with transthyretin cardiac amyloidosis confirmed by scintigraphy
- •Patient with signed consent
排除标准
- •Patients with systemic AL amyloidosis
- •Protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
- •Pregnant or breastfeeding woman
研究组 & 干预措施
Patients with transthyretin related cardiac amyloidosis
Bone scintigraphy
干预措施: bone scintigraphy (Diagnostic Test)
结局指标
主要结局
Measurement of SUVmax by quantitative analysis by bisphosphonate scintigraphy
时间窗: 6 months
次要结局
未报告次要终点