- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02930408
Compare Train and 3D-4D Left Ventricular Systolic Function in Subjects Suffering From Dystrophy and Healthy Subjects
October 11, 2016 updated by: Poitiers University Hospital
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Ventricular Ejection Fraction Left 3D
Time Frame: Immediately
|
Immediately
|
|
Global longitudinal systolic Strain
Time Frame: Immediately
|
Immediately
|
|
Strain of the dispersion index
Time Frame: Immediately
|
Immediately
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
October 10, 2016
First Submitted That Met QC Criteria
October 11, 2016
First Posted (Estimate)
October 12, 2016
Study Record Updates
Last Update Posted (Estimate)
October 12, 2016
Last Update Submitted That Met QC Criteria
October 11, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STEINECHO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.