search
Back to results

Compare Train and 3D-4D Left Ventricular Systolic Function in Subjects Suffering From Dystrophy and Healthy Subjects

Primary Purpose

Steinert's Disease

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
electrocardiogram
Echocardiography
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Steinert's Disease

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • patients suffering from muscular dystrophy type 1 followed CHU Poitiers.
  • age ≥ 18 years

Exclusion Criteria:

  • duration QRS> 120 ms ECG permanent ventricular stimulation
  • trouble segmental kinetic obvious to echocardiography in visual analysis

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Ventricular Ejection Fraction Left 3D
    Global longitudinal systolic Strain
    Strain of the dispersion index

    Secondary Outcome Measures

    Full Information

    First Posted
    October 10, 2016
    Last Updated
    October 11, 2016
    Sponsor
    Poitiers University Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02930408
    Brief Title
    Compare Train and 3D-4D Left Ventricular Systolic Function in Subjects Suffering From Dystrophy and Healthy Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Terminated
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Poitiers University Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    Steinert's disease is an orphan disease. The prognosis of patients with this disease is conditioned by cardiac involvement. Search an early stage alterations in contractile function in subjects suffering from dystrophy would detect patients at risk of sudden death. The first stage of work is to validate the tools to detect early stage of infringement systolic function in a population of patients with myotonic dystrophy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Steinert's Disease

    7. Study Design

    Study Phase
    Not Applicable
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    electrocardiogram
    Intervention Type
    Procedure
    Intervention Name(s)
    Echocardiography
    Primary Outcome Measure Information:
    Title
    Ventricular Ejection Fraction Left 3D
    Time Frame
    Immediately
    Title
    Global longitudinal systolic Strain
    Time Frame
    Immediately
    Title
    Strain of the dispersion index
    Time Frame
    Immediately

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Eligibility Criteria
    Inclusion Criteria: patients suffering from muscular dystrophy type 1 followed CHU Poitiers. age ≥ 18 years Exclusion Criteria: duration QRS> 120 ms ECG permanent ventricular stimulation trouble segmental kinetic obvious to echocardiography in visual analysis

    12. IPD Sharing Statement

    Learn more about this trial

    Compare Train and 3D-4D Left Ventricular Systolic Function in Subjects Suffering From Dystrophy and Healthy Subjects

    We'll reach out to this number within 24 hrs