Non-Invasive Evaluation of Myocardial Stiffness by Elastography Pediatric Cardiology Under
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Myocardial diastolic stiffness UltrafastEcho (kPa)
研究概览
简要总结
First, investigators must determine the physiological standards across age classes of myocardial stiffness estimated by Elastography in ultrafast (estimated right ventricular stiffness [VD] and left ventricular [LV]). This will be done in groups of children without heart condition, age group (10 children per group, four age groups [0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years]).
Secondly, investigators will evaluate myocardial stiffness Elastography (RV and LV) on different groups of children (same age group) with cardiomyopathy and examine correlations with the conventional parameters of systolic and diastolic function of both ventricles and with myocardial strain values. The total population of the study will be 120 children (40 healthy, 80 patients).
详细描述
Monocenter Prospective, open-label, non-randomized. All patients included in the study have a specific consultation built around a clinical examination and echocardiography, in two stages, with estimates of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and measures of all echocardiographic parameters estimated in children with a clinical ultrasound machine (Philips and General Electric).
Following this consultation, clinic and electrocardiographic monitoring period will be observed for 30 minutes, to ensure the safety of our procedure.
Required subjects: 40 healthy volunteers + 80 = 120 persons
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Age criteria met by group [0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years]
- •consultation for heart murmur
- •Recipient of a social protection scheme or entitled (excluding AME)
- •Signed informed consent by the holders of parental authority
- •Patients MHC nonobstructive:
- •Age criteria met by group [1 month-1 year 1 year-5 years]
- •Diagnostic criteria of non-obstructive HCM validated by the medical team of pediatric cardiology center (Necker)
- •Recipient of a social protection scheme or entitled (excluding AME)
- •Signed informed consent by the holders of parental authority
- •Patients primitive CMD:
- •Age criteria met by group [1 month-1 year 1 year-5 years]
- •Diagnostic criteria of primary CMD validated by the medical team of pediatric cardiology center (Necker)
- •Recipient of a social protection scheme or entitled (excluding AME)
- •Signed informed consent
排除标准
- •Healthy Patients:
- •Age> 15 years
- •Heart and Systemic Pathology identified
- •metabolic and tissue pathology.
- •known genetic pathology may have cardiac involvement.
- •No echogenicity,
- •Allergy echocardiography gel.
- •Group CMH primitive Patients
- •No echogenicity,,
- •Allergy echocardiography gel.
- •Arrhythmia.
- •Pacemaker or defibrillator
- •Patients primitive CMD:
- •No echogenicity,,
- •Allergy echocardiography gel.
- •Arrhythmia.
- •Pacemaker or defibrillator
研究组 & 干预措施
Group 2 Patients CMH primitive
Echography and Elastography To evaluate myocardial stiffness Elastography (RV and LV) on different groups of children (same age group) with Hypertrophic Cardiomyopathy (HCM) non obstructive primitive and examine correlations with the conventional parameters of systolic and diastolic function of both ventricles and with myocardial strain values.
干预措施: Elastography (Device)
Group 1 "healthy volunteers
Echography and Elastography To determine physiological standards across age classes of myocardial stiffness estimated by Elastography in ultrafast (estimated right ventricular stiffness [VD] and left ventricular [LV]). This will be done in groups of children without heart condition, age group (10 children per group, four age groups [0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years]).
干预措施: Echography (Device)
Group 1 "healthy volunteers
Echography and Elastography To determine physiological standards across age classes of myocardial stiffness estimated by Elastography in ultrafast (estimated right ventricular stiffness [VD] and left ventricular [LV]). This will be done in groups of children without heart condition, age group (10 children per group, four age groups [0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years]).
干预措施: Elastography (Device)
Group 2 Patients CMH primitive
Echography and Elastography To evaluate myocardial stiffness Elastography (RV and LV) on different groups of children (same age group) with Hypertrophic Cardiomyopathy (HCM) non obstructive primitive and examine correlations with the conventional parameters of systolic and diastolic function of both ventricles and with myocardial strain values.
干预措施: Echography (Device)
Group 3 Patients primitive CMD:
Echography and Elastography To evaluate myocardial stiffness Elastography (RV and LV) on different groups of children (same age group) with Dilated Cardiomyopathy primitive and examine correlations with the conventional parameters of systolic and diastolic function of both ventricles and with myocardial strain values.
干预措施: Echography (Device)
Group 3 Patients primitive CMD:
Echography and Elastography To evaluate myocardial stiffness Elastography (RV and LV) on different groups of children (same age group) with Dilated Cardiomyopathy primitive and examine correlations with the conventional parameters of systolic and diastolic function of both ventricles and with myocardial strain values.
干预措施: Elastography (Device)
结局指标
主要结局
Myocardial diastolic stiffness UltrafastEcho (kPa)
时间窗: through study completion, an average of 1 year
Normal values and intra-observer variability and inter-observer variability to demonstrate that the Aixplorer® myocardial elastography provides a reproducible assessment of myocardial stiffness.
次要结局
未报告次要终点