Venous Thromboembolism in DM1 (DM1-VTE)
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ClinicalTrials.gov Identifier: NCT03141749 |
Recruitment Status :
Completed
First Posted : May 5, 2017
Last Update Posted : May 9, 2017
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Condition or disease |
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Venous Thromboembolism Pulmonary Embolism Deep Vein Thrombosis Myopathy Myotonic Dystrophy 1 |
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 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 |

- Any episode of pulmonary embolism and/or deep vein thrombosis, diagnosed according to 2011 AHA guidelines on venous thromboembolism management [ Time Frame: 14 years ]

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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 |
Inclusion Criteria:
- Age > 18 years
- Genetically proven myopathy
- Admission in our institutions from January 2000 to November 2014
Exclusion Criteria:
- Patient refusal

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
Principal Investigator: | Karim Wahbi, MD, PhD | Institut de Myologie, Paris, FRANCE |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |