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Venous Thromboembolism in DM1 (DM1-VTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03141749
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Institut de Myologie, France

Study Description
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Brief Summary:
The risk for venous thromboembolism (VTE) in DM1 and in other inherited myopathies, which can lead to chronic immobilization, are unknown. The purpose of this study is to evaluate incidence of VTE in cohort of patients presenting with DM1 with a comparison to a group of other inheritable myopathies and to a community-based population.

Condition or disease
Venous Thromboembolism Pulmonary Embolism Deep Vein Thrombosis Myopathy Myotonic Dystrophy 1

Detailed Description:

A cohort of more that 2,800 adult patients admitted to our Institutions between January 2000 and November 2014 with genetically proven myopathy will be retrospectively included.

Any information relative to their demographic and genetic characteristics, their muscular functional status and the occurrence of VTE will be collected.

Statistical analysis will be performed to estimate the incidence of venous thromboembolism in this population, to identify predictors of VTE, and to compare its incidence to a community-based population.

Study Design
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Study Type : Observational
Actual Enrollment : 2810 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Incidence and Predictors of Venous Thromboembolism in Myotonic Dystrophy
Actual Study Start Date : January 2000
Actual Primary Completion Date : November 2014
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Any episode of pulmonary embolism and/or deep vein thrombosis, diagnosed according to 2011 AHA guidelines on venous thromboembolism management [ Time Frame: 14 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with genetically proven myopathy
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Genetically proven myopathy
  • Admission in our institutions from January 2000 to November 2014

Exclusion Criteria:

  • Patient refusal
Contacts and Locations
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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): NCT03141749


Sponsors and Collaborators
Institut de Myologie, France
Investigators
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Principal Investigator: Karim Wahbi, MD, PhD Institut de Myologie, Paris, FRANCE
More Information
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Responsible Party: Institut de Myologie, France
ClinicalTrials.gov Identifier: NCT03141749    
Other Study ID Numbers: Institutmyologie
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myotonic Dystrophy
Pulmonary Embolism
Thrombosis
Thromboembolism
Embolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
 Respiratory Tract Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Muscular Dystrophies
Muscular Disorders, Atrophic
Myotonic Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn