Venous Thromboembolism in DM1

NCT ID: NCT03141749

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2810 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2000-01-31
• Study Completion Date: 2017-01-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Patient refusal

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Myologie, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karim Wahbi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut de Myologie, Paris, FRANCE

Other Identifiers

Institutmyologie

Identifier Type: -

Identifier Source: org_study_id