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NCT03141749 Clinical Trial

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
Secondary ID
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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