DM1 Heart Registry - DM1 Respiratory Registry (DM1-Heart-R)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karim WAHBI, Institut de Myologie, France
ClinicalTrials.gov Identifier:
NCT01136330
First received: June 2, 2010
Last updated: February 17, 2012
Last verified: February 2012

June 2, 2010
February 17, 2012
May 2010
September 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01136330 on ClinicalTrials.gov Archive Site
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DM1 Heart Registry - DM1 Respiratory Registry
Cardiac and Respiratory Prognostic Factors in Patients With Myotonic Dystrophy Type 1

Myotonic dystrophy type 1 (DM1) is the most frequent neuromuscular disease in adults. DM1 patients have an impaired prognosis (mean age of death <60 years) due to cardiac and respiratory complications.

Our primary objective was to identify cardiac and respiratory prognostic factors in DM1.

  1. Patients with genetically proven DM1 who were admitted in Pitié Salpêtrière Hospital from 2000 and 2010 will be identified. These patients systematically underwent neurological, cardiac and respiratory investigations.
  2. Baseline medical and genetic information will be entered in a dedicated database, including cardiac and respiratory investigations.
  3. The occurence of severe cardiac and respiratory adverse events will also be collected.
  4. Statistical analysis will be performed to look for correlations between baseline patient characteristics and cardiac or respiratory adverse events during follow up.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

Myotonic dystrophy type 1

Myotonic Dystrophy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
914
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • DM1 mutation (>50 CTG repeats)
  • Age > 18 years

Exclusion Criteria:

  • Patient refusal
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01136330
AFM-13286
No
Karim WAHBI, Institut de Myologie, France
Institut de Myologie, France
Not Provided
Study Director: Denis Duboc, MD,PhD APHP
Institut de Myologie, France
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP