NCT05150353已完成不适用
Detection of Amyloid Deposits in the Wrist by MRI With Mapping and High Resolution Sequences in Systemic Amyloidosis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- T1 measurement (ms) associated with each of the 5 regions of interest at the wrist
研究概览
简要总结
This study is based on the hypothesis that MRI could make it possible to non-invasively detect these amyloid deposits at the level of the wrist using parametric sequences known as T1 mapping, in the form of an extension of T1 in the wrists. areas where amyloid deposits are found in the wrist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- 是
入选标准
- •Patient group:
- •Woman or man over 18 years old
- •With ATTR or AL cardiac amyloidosis with or without carpal tunnel. The diagnosis of amyloidosis must be proven by a positive myocardial biopsy or diphosphonate scintigraphy.
- •Affiliate or beneficiarie of a social security scheme.
- •Having signed the free and informed consent.
- •Healthy volunteers:
- •Woman or man over 18 years old
- •Affiliate or beneficiarie of a social security scheme.
- •Having signed the free and informed consent.
排除标准
- •Patient group:
- •Patients participating in another clinical study.
- •Patients suffering from rheumatoid arthritis or other autoimmune disease (vasculitis, lupus, scleroderma, etc.)
- •Patients with a medical history of wrist surgery (exclude the operated side).
- •Patients with a contraindication to performing an MRI (pacemaker, etc.)
- •Pregnant or breastfeeding women.
- •Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision.
- •Healthy volunteer:
- •Volunteers participating in another clinical study.
- •Volunteers suffering from rheumatoid arthritis or other autoimmune disease (vasculitis, lupus, scleroderma, etc.)
- •Pregnant or breastfeeding women.
- •Volunteer with a contraindication to performing an MRI (pacemaker, etc.)
- •Protected volunteers: Adults under guardianship, guardianship or other legal protection, deprived of their liberty by judicial or administrative decision.
研究组 & 干预措施
Patients with cardiac amyloidosis
Experimental
干预措施: MRI (Procedure)
Healthy volunteers
Placebo Comparator
干预措施: MRI (Procedure)
结局指标
主要结局
T1 measurement (ms) associated with each of the 5 regions of interest at the wrist
时间窗: 1 day
次要结局
未报告次要终点
研究者
研究点 (2)
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