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Venous Thromboembolism in DM1 (DM1-VTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03141749
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Institut de Myologie, France

Tracking Information
First Submitted Date May 3, 2017
First Posted Date May 5, 2017
Last Update Posted Date May 9, 2017
Actual Study Start Date January 2000
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 5, 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 ]
Original Primary Outcome Measures
 (submitted: May 3, 2017)
Venous thromboembolism [ Time Frame: 14 years ]
Pulmonary embolism and/or deep vein thrombosis
Change History Complete list of historical versions of study NCT03141749 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Venous Thromboembolism in DM1
Official Title Incidence and Predictors of Venous Thromboembolism in Myotonic Dystrophy
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients with genetically proven myopathy
Condition
  • Venous Thromboembolism
  • Pulmonary Embolism
  • Deep Vein Thrombosis
  • Myopathy
  • Myotonic Dystrophy 1
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 3, 2017)
2810
Original Actual Enrollment Same as current
Actual Study Completion Date January 2017
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient refusal
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03141749
Other Study ID Numbers Institutmyologie
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Institut de Myologie, France
Study Sponsor Institut de Myologie, France
Collaborators Not Provided
Investigators
Principal Investigator: Karim Wahbi, MD, PhD Institut de Myologie, Paris, FRANCE
PRS Account Institut de Myologie, France
Verification Date May 2017