跳至主要内容
临床试验/NCT06282822
NCT06282822尚未招募不适用

Multimodal Ultrasound Radiomics Based on Shear Wave Elastography for Accurate Diagnosis of Heart Failure With Preserved Ejection Fraction: A Prospective Multicenter Study

First Hospital of China Medical University0 个研究点目标入组 800 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
800
主要终点
Shear wave velocity

研究概览

简要总结

The diagnosis of heart failure with preserved ejection fraction (HFpEF) is often complex. Echocardiography has the advantages of being a non-invasive, simple operation, low price, and high repeatability, and is of great value in the diagnosis of HFpEF. However, the current echocardiographic assessment of left ventricular diastolic dysfunction and elevated filling pressure is based on multi-parameter indirect judgment, and new parameters are urgently needed to achieve accurate judgment of left ventricular diastolic function and an accurate diagnosis of HFpEF. Myocardial stiffness refers to the ability of the myocardium to undergo stress and strain. It is an important part of the pathophysiology of cardiac diastolic dysfunction and an important parameter for clinical evaluation of the diastolic function of HFpEF. Shear-wave elastography is a novel ultrasound-based elastography technology. Based on the shear wave generated by the remote induction of the radiation force of the focused ultrasound beam, the hardness of myocardial tissue can be measured quantitatively, locally, and noninvasively, and the change in myocardial stiffness in patients with HFpEF can be directly reflected. Currently, no relevant studies have applied shear-wave elastography to the diagnosis of HFpEF. This study aims to identify changes in myocardial stiffness measured by shear-wave elastography in patients with HFpEF based on a multicenter study and apply myocardial stiffness parameters to the diagnosis of HFpEF.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age ≥18 years old
  • Clear epidemiological and population characteristics of HFpEF
  • Symptoms and/or signs of heart failure
  • Echocardiographic examination of LVEF≥50%
  • Objective evidence of cardiac structural and/or functional abnormalities consistent with left ventricular diastolic dysfunction and/or elevated left ventricular filling pressure, including elevated levels of natriuretic peptides
  • HFpEF score ≥6 or HFA-PEFF score ≥5

排除标准

  • Any one item per patient was excluded from the study:
  • Arrhythmia.
  • ischemic heart disease.
  • Valvular heart disease or congenital heart disease with severe hemodynamic changes.
  • History of pacemaker implantation or other cardiac surgery.
  • Poor ultrasonic image quality cannot meet the parameter measurement and analysis.

结局指标

主要结局

Shear wave velocity

时间窗: Completed within 2 weeks of enrollment

次要结局

未报告次要终点

研究者

发起方
First Hospital of China Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chunyan Ma

Professor

First Hospital of China Medical University

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