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临床试验/NCT03895541
NCT03895541招募中不适用

Noninvasive Elastography Evaluation of Myocardial Stiffness in Elderly Patients With Isolated Diastolic Heart Failure: New Diagnostic Tool?

French Cardiology Society2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年1月24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
发起方
入组人数
90
试验地点
2
主要终点
Myocardial rigidity assessment

研究概览

简要总结

The new approach propose in this protocol is based on ultrafast ultrasound and remote palpation of tissue by ultrasonic radiation pressure. Ultrafast ultrasound of biological tissues is based on an innovative ultrasound imaging approach that can image very fast soft tissue events at a rate of several thousands of frames per second and provide quantitative mapping of the elasticity of the tissues. This current project aims is to focus on myocardial rigidity in diastole to better assess the function of the heart failure.

详细描述

Diastolic heart failure or heart failure with preserved systolic function is the leading cause of heart failure in elderly subjects (more than 2/3 of heart failure in subjects over 60 years). Its main etiology is high blood pressure. Diagnosis of diastolic heart failure remains controversial in clinical practice. It is based on ultrasound and biological criteria. These are mainly acute edema of the lung for patients with preserved Ejection Fraction and high Brain Natriuretic Peptid. It is now recognized that the "primum movens" of this type of heart failure is the increase in myocardial stiffness secondary to left ventricular hypertrophy. The noninvasive evaluation of this parameter would allow a more accurate and reliable diagnosis since it does not depend on the loading conditions, unlike the heart failure and the trans-mitral Doppler). However, the absence of a non-invasive tool for the direct evaluation of diastolic (so-called passive) rigidity prevents the use of this diagnostic parameter. Investigators propose here to non-invasively evaluate the myocardial stiffness in the elderly patient with diastolic heart failure thanks to a new imaging tool using an innovative ultrasonic technology, the ultrafast-echo associated with its elastographic mode "ShearWave Imaging". Investigators have been working for several years in collaboration with the Langevin Institute on this technology, which has recently been validated on experimental models. Its principle is based on the creation of a shear wave from a standard ultrasound probe and the calculation of the velocity of this wave thanks to the very high temporal resolution of the ultrasound system, this speed being correlated to the myocardial rigidity. The human study was recently made possible by the development of a phased array probe with the ability to work with the elastography mode ("ShearWave Imaging").

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
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Global Inclusion Criteria:
  • Hospitalization in cardiology services for acute pulmonary edema during heart failure
  • Natriuretic peptide type B ≥35 pg/ml
  • Echocardiographic structural alteration
  • Specific Inclusion criteria
  • Group "preserved LVEF": Left ventricular Ejection Fraction ≥50%
  • Group "moderate alteration of LVEF": Left ventricular Ejection Fraction between 40% and 49%
  • Group "Systolic heart failure": Left ventricular Ejection Fraction< 40%

排除标准

  • Other associated lung pathology
  • Other heart disease
  • Contraindication to MRI or echocardiography gel
  • Pregnancy
  • Poor echogenicity,

研究组 & 干预措施

Stratification

Other

All patient will have the same intervention. They will be stratified regarding their degree of heart failure gravity.

干预措施: SuperSonic image (Diagnostic Test)

结局指标

主要结局

Myocardial rigidity assessment

时间窗: Day 1

Myocardial rigidity measured using this new non-invasive ultrasound imaging technique.

次要结局

  • Norms estimation of myocardial rigidity(Day 1)
  • Safety of cardiac elastography(Day 1)

研究者

发起方
French Cardiology Society
申办方类型
Other
责任方
Sponsor

研究点 (2)

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