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

Primary Purpose

Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Echography
Elastography
Sponsored by
French Cardiology Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dilated Cardiomyopathy focused on measuring Child

Eligibility Criteria

1 Day - 15 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chu Necker

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Group 1 "healthy volunteers

Group 2 Patients CMH primitive

Group 3 Patients primitive CMD:

Arm 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]).

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 23, 2015
Last Updated
October 31, 2017
Sponsor
French Cardiology Society
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1. Study Identification

Unique Protocol Identification Number
NCT02619825
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Cardiology Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy
Keywords
Child

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 "healthy volunteers
Arm Type
Other
Arm 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]).
Arm Title
Group 2 Patients CMH primitive
Arm Type
Other
Arm Description
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.
Arm Title
Group 3 Patients primitive CMD:
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Echography
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Elastography
Intervention Description
cardiac ultrasound, in two stages, with an estimate of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and
Primary Outcome Measure Information:
Title
Myocardial diastolic stiffness UltrafastEcho (kPa)
Description
Normal values and intra-observer variability and inter-observer variability to demonstrate that the Aixplorer® myocardial elastography provides a reproducible assessment of myocardial stiffness.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier VILLEMAIN, MD
Organizational Affiliation
LAngevin Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Chu Necker
City
Paris
ZIP/Postal Code
75005
Country
France

12. IPD Sharing Statement

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

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