跳至主要内容
临床试验/NCT03322319
NCT03322319已完成不适用

acTive scrEening of cArdiac aMyloidosis in the Caribbean's

University Hospital Center of Martinique2 个研究点 分布在 2 个国家目标入组 175 人开始时间: 2013年9月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
175
试验地点
2
主要终点
Diagnosis of cardiac amyloidosis.

研究概览

简要总结

The frequency of cardiac amyloidosis among patients presenting with a so-called left ventricular hypertrophy remains unknown. This problem is especially relevant in the Caribbean's, where an amyloidosis-prone mutation of transthyretin gene might be frequent.

详细描述

Cardiac amyloidosis is a very poorly known disease, in its frequency, its mechanisms, its treatment. This lack of knowledge is a major limitation to the improvement, indispensable, of the care of the patients. In clinical routine, particularly in West Indies-Guyana, cardiac amyloidosis is a disease poorly identified, whose management remains to be optimized. Concordant observations suggest that the frequency of the disease could be significant in the Antilles-Guyana: aging of the population, high frequency of an amyloidogenic mutation (Val122Il mutation of the transthyretin gene) found in 4% of the Afro-American population, recent identification in Martinique by a neurology team of a new founding mutation of the transthyretin gene that may cause the disease.

These elements justified the setting up of a multidisciplinary group whose objective is to contribute to the improvement of screening, treatment, and follow-up of patients with cardiac amyloidosis.

An identical diagnostic algorithm will be followed in all centers. Therapeutic management will be left to the discretion of the health care teams, who will be communicated regularly, the latest management recommendations.

A frequency of 30% is expected and will be assessed with a power of 80% and an alpha risk of 0.05. Quantitative and qualitative data will be described as usual. Differences between groups will be assessed with parametric or non-parametric tests.

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

  • •Age > 18 years,
  • •Residency in French Caribbean Regions
  • •Access to healthcare coverage,
  • •Written informed consent obtained

排除标准

  • •Evidence of another cause for left ventricular hypertrophy (uncontrolled severe high blood pressure, untreated severe aortic stenosis, family history of hypertrophic cardiomyopathy)
  • •Inability to deliver informed consent,
  • •Presence of a known severe disease impending participation in the study

研究组 & 干预措施

left Ventricular Hypertrophy

Experimental

Patients with left ventricular wall thickness measuring 15mm or more, or patients with a suggestive left ventricular echogenicity. Procedure/surgery will be performed following a diagnostic tree.

干预措施: Tissue biopsies (Procedure)

结局指标

主要结局

Diagnosis of cardiac amyloidosis.

时间窗: 3 months

Diagnosis procedures involve clinical exam, echocardiography, MRI, SPECT, tissue biopsies, and will be realized following a diagnostic tree.

次要结局

  • Subtyping of cardiac amyloidosis(2 years)

研究者

发起方
University Hospital Center of Martinique
申办方类型
Other
责任方
Sponsor

研究点 (2)

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