Venous Thromboembolism in DM1

Pulmonary Embolism Clinical Trial

— DM1-VTE  

Official title:

Incidence and Predictors of Venous Thromboembolism in Myotonic Dystrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141749
• Other study ID #: Institutmyologie
• Status: Completed
• Phase: N/A
• First received: May 3, 2017
• Last updated: May 5, 2017
• Start date: January 2000
• Est. completion date: January 2017

Study information

• Verified date: May 2017
• Source: Institut de Myologie, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2810
• Est. completion date: January 2017
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Genetically proven myopathy

• Admission in our institutions from January 2000 to November 2014

Exclusion Criteria:

• Patient refusal

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Myologie, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any episode of pulmonary embolism and/or deep vein thrombosis, diagnosed according to 2011 AHA guidelines on venous thromboembolism management		14 years