Skip to main content
OpenTrials
Completed

NCT Number: NCT02619825

Non-Invasive Evaluation of Myocardial Stiffness by Elastography in Pediatric Cardiology (Elasto-Pédiatrie)

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dilated Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiomyopathy, Hypertrophic Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Heart Valve Diseases Hypertrophic Cardiomyopathy Laminopathies

Age range

1 day–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Necker

Paris, 75005, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Group 1. 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

Group 2. 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

Group 3. 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

Exclusion criteria

Group 1. 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 2. Group CMH primitive Patients

  • No echogenicity,,
  • Allergy echocardiography gel.
  • Arrhythmia.
  • Pacemaker or defibrillator

Group 3. Patients primitive CMD:

  • No echogenicity,,
  • Allergy echocardiography gel.
  • Arrhythmia.
  • Pacemaker or defibrillator

Treatment and study plan

Echography

Device

cardiac ultrasound, in two stages, with an estimate of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and measurement of all echocardiographic parameters estimated in children with a clinical ultrasound Machine

Elastography

Device

cardiac ultrasound, in two stages, with an estimate of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and

Primary outcomes

  1. Myocardial diastolic stiffness UltrafastEcho (kPa)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Official study title

Non-Invasive Evaluation of Myocardial Stiffness by Elastography Pediatric Cardiology Under

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 2, 2015
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.