Venous Thromboembolism in DM1

Completed

• Conditions: Myopathy; Venous Thromboembolism; Myotonic Dystrophy 1; Pulmonary Embolism; Deep Vein Thrombosis

• Registration Number: NCT03141749
• Lead Sponsor: Institut de Myologie, France

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.

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 Timeline

• Study Start: 2000-01
• Primary Completion: 2014-11
• Study Completion: 2017-01
• Status Verified: 2017-05
• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-05
• Last Update Submitted: 2017-05-05
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2810

Inclusion Criteria

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

Exclusion Criteria

• Patient refusal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any episode of pulmonary embolism and/or deep vein thrombosis, diagnosed according to 2011 AHA guidelines on venous thromboembolism management	14 years