Status:

COMPLETED

Venous Thromboembolism in Myotonic Dystrophy Type 1

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Collaborating Sponsors:

AFM-Téléthon (Funding)

Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

Conditions:

Myotonic Dystrophy 1

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Investigators identified a high risk of deep vein thrombosis and pulmonary embolism in patients presenting myotonic dystrophy type 1 treated in our hospital, 10 times higher than general population ma...

Detailed Description

Investigators have identified in the cohort of 1084 patients presenting myotonic dystrophy type 1 (DM1) a 10% prevalence of venous thromboembolism (VTE) and a 7‰ annual incidence, which is 10-fold hig...

Eligibility Criteria

Inclusion

  • Population N°1
  • Age over 18 years
  • Patient living in France and with medical insurance
  • Patient having given his informed and written consent
  • DM1 groups: genetically proven DM1
  • VTE groups: at least 1 history of VTE (PE and/or DVT)
  • Healthy volunteers: patient without any medical history (no DM1, no VTE, no thrombophilia), and without taking any anti-thrombotic medication
  • Population N°2
  • Liver tissue of patients with genetically proven DM1 (tissue bank)
  • Liver tissue of patients without DM1 or any history of VTE (tissue bank)

Exclusion

  • Patient opposed to data collection and analysis
  • 1\. Population N°1
  • Genetically proven thrombophilia
  • Anti-thrombotic medication
  • Hemoglobin levels \< 7 g/dL
  • Hemoglobin levels \< 9 g/dL in case of cardiac of respiratory condition
  • 2\. Population N°2
  • Liver tissue quality insufficient for RNA extraction and analysis

Key Trial Info

Start Date :

June 11 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 15 2023

Estimated Enrollment :

130 Patients enrolled

Trial Details

Trial ID

NCT03424460

Start Date

June 11 2018

End Date

March 15 2023

Last Update

September 12 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Service de Cardiologie - Hôpital Cochin

Paris, Île-de-France Region, France, 75014