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

NCT02619825 | Completed

• 1 other identifier: 2014-03
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Dilated Cardiomyopathy; Hypertrophic Cardiomyopathy

Keywords

Child

Outcome Measures

Primary Outcomes (1)

• Myocardial diastolic stiffness UltrafastEcho (kPa)

  Normal values and intra-observer variability and inter-observer variability to demonstrate that the Aixplorer® myocardial elastography provides a reproducible assessment of myocardial stiffness.

  through study completion, an average of 1 year

Study Arms (3)

Group 1 "healthy volunteers

OTHER

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 \[0-1mois, 1 month-1 year 1 year-5 years, 5 years-15years\]).

Device: Echography; Device: Elastography

Group 2 Patients CMH primitive

OTHER

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.

Device: Echography; Device: Elastography

Group 3 Patients primitive CMD:

OTHER

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.

Device: Echography; Device: Elastography

Interventions

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

Group 1 "healthy volunteers; Group 2 Patients CMH primitive; Group 3 Patients primitive CMD:

Elastography DEVICE

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

Group 1 "healthy volunteers; Group 2 Patients CMH primitive; Group 3 Patients primitive CMD:

Eligibility Criteria

• Age: 1 Day - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• French Cardiology Society: lead

Study Sites (1)

Chu Necker

Paris, 75005, France

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Cardiomyopathy, Hypertrophic

Interventions

Ultrasonography; Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Olivier VILLEMAIN, MD

  LAngevin Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: December 2, 2015
• Study Start: November 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-10

Locations

FR (1)