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临床试验/NCT04636684
NCT04636684招募中不适用

Prevalence and Significance of ATTR Aortic Valve Amyloidosis in Degenerative Aortic Stenosis

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
prevalence rate of valvular ATTR amyloidosis

研究概览

简要总结

Cardiac amyloidosis is a restrictive cardiomyopathy with a potentially severe prognosis that can be life-threatening. It is linked in the vast majority of cases to a light chain deposition of immunoglobulin or transthyretin. Although myocardial involvement is predominant, other locations are possible: the atrioventricular conduction system, coronary arteries and valve leaflets. In systematic histological analyzes, deposits of amyloidosis infiltrating the aortic valve have been reported with a frequency of up to 74% for degenerative RA. The nature of these deposits has never been established because the immunostaining carried out all remained negative, probably due to decalcification prior to cutting. Currently, these deposits are considered to be local degenerative phenomena without clinical repercussions. However, the use of bone scintigraphy has shown a high prevalence, between 14 and 16%, of ATTR cardiac amyloidosis in patients with severe RA. The diagnosis of ATTR amyloidosis has been proven histologically in a few patients. Sequencing of the TTR gene has shown that they are mainly wild forms. In fact, the prevalence of transthyretin mutations in our local cohort is 20%.

The objective of this study is to determine by proteomic analysis based on mass spectrometry, the prevalence of ATTR aortic valve amyloidosis in patients undergoing surgical valve replacement for degenerative aortic stenosis.

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient over 18 years old
  • Degenerative aortic stenosis
  • Aortic valve replacement surgery
  • Signature of the informed consent form

排除标准

  • Non-degenerative aortic stenosis: bicuspid, rheumatic disease, aortic regurgitation
  • Persons under a system of legal protection for adults (guardianship, curatorship, etc.)
  • Pregnant women

研究组 & 干预措施

patients undergoing surgical valve replacement for degenerative aortic stenosis

Experimental

干预措施: Proteomic analysis (Diagnostic Test)

结局指标

主要结局

prevalence rate of valvular ATTR amyloidosis

时间窗: 1 year

calculation of the prevalence rate of valvular ATTR amyloidosis with its 95% confidence interval.

次要结局

  • percentage of wild ATTR myocardial amyloidosis(1 year)
  • Prevalence of ATTR myocardial amyloidosis revealed by bone scintigraphy(1 year)
  • percentage of mutated ATTR myocardial amyloidosis(1 year)
  • Prevalence of types of amyloidosis other than ATTR(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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