2D Strain Evaluation: Children With Duchenne Muscular Dystrophy Versus Healthy Children

NCT ID: NCT02418338

Last Updated: 2019-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-06-30

Brief Summary

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Compare systolic function of left ventricle (LV) and right ventricle (VD) by 2D strain evaluation in Duchenne muscular dystrophy children versus a control group.

Detailed Description

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Among the new echocardiographic techniques, two dimensional Speckle Tracking Imaging or "2D Strain" allows a dynamic study of regionalized and global ventricular contraction. With software for the spatial and temporal processing of a standard 2D image, this technique measures the displacement of natural markers present on the myocardial wall.

Used in adult cardiology since 2000, it could be eligible to pediatric population because of many potential applications. In Duchenne muscular dystrophy, myocardial disease leads to death in the third decade. Early diagnosis and preventive therapy remain a challenge. No clinic, biologic or radiologic markers can predict myocardial disease before advanced and irreversible heart failure.

Recent animals and human studies suggest that 2D strain anomalies could predict left ventricular systolic dysfunction in Duchenne muscular dystrophy. If it is confirmed, 2D strain could be used as early marker of myocardial disease in routine patient follow-up and in future therapeutic studies.

Purpose : - To compare systolic function of left ventricle (LV) and right ventricle (RV) by 2D strain evaluation in Duchenne muscular dystrophy children versus a control group.

* To correlate 2D Strain variables to conventional LV and RV echo variables.
* To evaluate 2D strain feasibility in normal children and Duchenne muscular myopathy population

Conditions

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Duchenne Muscular Dystrophy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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dmd children

echocardiography

Group Type EXPERIMENTAL

speckle tracking (2D strain) echocardiography

Intervention Type OTHER

2D echocardiography videos of both ventricles to perform 2D strain post-examination evaluation

healthy children

echocardiography

Group Type OTHER

speckle tracking (2D strain) echocardiography

Intervention Type OTHER

2D echocardiography videos of both ventricles to perform 2D strain post-examination evaluation

Interventions

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speckle tracking (2D strain) echocardiography

2D echocardiography videos of both ventricles to perform 2D strain post-examination evaluation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Duchenne's muscular dystrophy (group 1) followed in our institution's referral center of neuromuscular diseases, during regular annual echocardiography follow-up.
* Healthy children (group 2), addressed in pediatric cardiology
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal AMEDRO, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UH Montpellier

Pierre MP Meyer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UH Montpellier

Arnaud BERTRAND, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UH Montpellier

Jean-Michel RAUZIER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UH Nîmes

Charlène BREDY, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UH Montpellier

François RIVIER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UH Montpellier

Grégoire DE LA VILLEON, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UH Montpellier

Ulrike WALTHER-LOUVIER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UH Montpellier

Sophie GUILLAUMONT, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UH Montpellier

Camille SOULATGES, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UH Montpellier

Marie VINCENTI, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UH Montpellier

Locations

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Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital

Montpellier, , France

Site Status

Countries

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France

References

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Amedro P, Vincenti M, De La Villeon G, Lavastre K, Barrea C, Guillaumont S, Bredy C, Gamon L, Meli AC, Cazorla O, Fauconnier J, Meyer P, Rivier F, Adda J, Mura T, Lacampagne A. Speckle-Tracking Echocardiography in Children With Duchenne Muscular Dystrophy: A Prospective Multicenter Controlled Cross-Sectional Study. J Am Soc Echocardiogr. 2019 Mar;32(3):412-422. doi: 10.1016/j.echo.2018.10.017. Epub 2019 Jan 21.

Reference Type BACKGROUND
PMID: 30679141 (View on PubMed)

Lanot N, Vincenti M, Abassi H, Bredy C, Agullo A, Gamon L, Mura T, Lavastre K, De La Villeon G, Barrea C, Meyer P, Rivier F, Meli AC, Fauconnier J, Cazorla O, Lacampagne A, Amedro P. Assessment of left ventricular dyssynchrony by speckle tracking echocardiography in children with duchenne muscular dystrophy. Int J Cardiovasc Imaging. 2022 Jan;38(1):79-89. doi: 10.1007/s10554-021-02369-y. Epub 2021 Dec 14.

Reference Type DERIVED
PMID: 34905152 (View on PubMed)

Other Identifiers

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9458

Identifier Type: -

Identifier Source: org_study_id

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