Brief Title
Non-Invasive Evaluation of Myocardial Stiffness by Elastography in Pediatric Cardiology (Elasto-Pédiatrie)
Official Title
Non-Invasive Evaluation of Myocardial Stiffness by Elastography Pediatric Cardiology Under
Brief Summary
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).
Detailed Description
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
Study Type
Interventional
Primary Outcome
Myocardial diastolic stiffness UltrafastEcho (kPa)
Condition
Dilated Cardiomyopathy
Intervention
Echography
Study Arms / Comparison Groups
Group 1 "healthy volunteers
Description: 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]).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
120
Start Date
November 2015
Completion Date
July 2017
Primary Completion Date
May 2017
Eligibility Criteria
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
Gender
All
Ages
N/A - 15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Olivier VILLEMAIN, MD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT02619825
Organization ID
2014-03
Responsible Party
Sponsor
Study Sponsor
French Cardiology Society
Study Sponsor
Olivier VILLEMAIN, MD, Study Chair, LAngevin Institute
Verification Date
October 2017