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临床试验/NCT07255144
NCT07255144招募中不适用

Ultrafast Ultrasound Imaging: Application in Pediatric Cardiology: Cardiac Ultrafast

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年3月11日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Myocardial stiffness

研究概览

简要总结

About 13 in 1000 children are born with heart disease. Current tools poorly assess heart filling in children, limiting treatment. This study explores ultrafast ultrasound imaging to measure heart stiffness and perfusion in children with congenital heart disease.

详细描述

About 13/1000 children are born with heart disease. As a result of better treatment, there is an increasing population of children surviving with congenital heart disease (CHD) as well as a growing number of children with obesity, hypertension and serious chronic diseases, such as cancer and kidney disease, who are at risk of developing heart disease. All of these diseases affect the heart muscle and one of the main mechanisms resulting in heart muscle damage is the development of scar tissue (fibrosis). Fibrosis makes the heart muscle stiffer and therefore more difficult to fill. The heart must fill properly with blood in order to function well; but it is very difficult to study the filling of the heart using current diagnostic tools. One of the main challenges in pediatric cardiology is that non-invasive diagnostic approaches used in adult patients to assess heart filling (diastolic function) have proven inadequate in children. This knowledge gap has limited therapeutic progress in this vulnerable population; and to date there is no effective therapy that improves the filling of the heart.

The aim of this study is to explore new potential of ultrasound to assess diastolic function in CHD children. Ultrafast ultrasound imaging (UFUS), consisting of ultrasound images at a very high rate, is a new ultrasound approach to assess cardiac function.

Using a Verasonics system (ultrasound open platform), we will assess the myocardial stiffness and the myocardial perfusion by UFUS.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Every patient of CHD department of any age or any sex:
  • Patients with CHD
  • General population patients in good general health as evidenced by medical history coming to our department for a check-up OR diagnosed with small Atrial Septal Defect or small Patent Foramen Ovale
  • Social security affiliation
  • Parental or legal guardian's non-opposition

排除标准

  • Arrhythmia
  • Segmental kinetic disorder.
  • Pacemaker or multisite stimulation, defibrillator,
  • Allergy to echocardiography gel.

结局指标

主要结局

Myocardial stiffness

时间窗: Baseline

assessed with ultrasound data processed using the Verasonics system, to evaluate diastolic function

Myocardial perfusion

时间窗: Baseline

assessed with ultrasound data processed using the Verasonics system, to evaluate diastolic function

次要结局

  • Echocardiographic parameters(Baseline)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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