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Trial record 92 of 157 for:    Idiopathic Dilated Cardiomyopathy

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

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ClinicalTrials.gov Identifier: NCT02619825
Recruitment Status : Completed
First Posted : December 2, 2015
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
French Cardiology Society

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).


Condition or disease Intervention/treatment Phase
Dilated Cardiomyopathy Hypertrophic Cardiomyopathy Device: Echography Device: Elastography Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-Invasive Evaluation of Myocardial Stiffness by Elastography Pediatric Cardiology Under
Actual Study Start Date : November 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : July 2017


Arm Intervention/treatment
Group 1 "healthy volunteers
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
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

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

Group 2 Patients CMH primitive
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
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

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

Group 3 Patients primitive CMD:
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
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

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




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02619825


Locations
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France
Chu Necker
Paris, France, 75005
Sponsors and Collaborators
French Cardiology Society
Investigators
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Study Chair: Olivier VILLEMAIN, MD LAngevin Institute

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Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT02619825     History of Changes
Other Study ID Numbers: 2014-03
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Keywords provided by French Cardiology Society:
Child
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Cardiomegaly