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

Hypertrophic Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02619825
• Other study ID #: 2014-03
• Status: Completed
• Phase: N/A
• First received: October 23, 2015
• Last updated: October 31, 2017
• Start date: November 2015
• Est. completion date: July 2017

Study information

• Verified date: October 2017
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Cardiomyopathy, Hypertrophic
• Dilated Cardiomyopathy
• Hypertrophic Cardiomyopathy
• Hypertrophy

Intervention

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

Locations

Country	Name	City	State
France	Chu Necker	Paris

Sponsors (1)

Lead Sponsor	Collaborator
French Cardiology Society

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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