Medical Complications in Familial and Multifactorial Chylomicronaemia Syndromes (ESTHYM)
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|ClinicalTrials.gov Identifier: NCT03912181|
Recruitment Status : Completed
First Posted : April 11, 2019
Last Update Posted : April 11, 2019
A retrospective, systematic study of reimbursed healthcare costs over a 10 year period in patients suffering from Familial Chylomicronaemia Syndromes (FCS) or Multifactorial Chylomicronaemia Syndromes (MCS) in order to establish the relative healthcare burden of both syndromes by linking the Hospices Civils de Lyon (HCL) registry of FCS or MCS patients and data obtained from FCS or MCS patients followed in Paris, Nantes and Lyon to the French National Health System (NHS) healthcare claims database, the Système National d'Information Inter-Régimes de l'Assurance Maladie (SNIIR-AM).
A probabilistic approach will be used to link databases. This linkage will be based on the following variables: age, gender, date of discharge of any hospitalization, date of any imaging procedure.
This study will help to describe, in real life, the management of severe hyperglyceridaemia in France. In addition, the descriptive results will help obtain a better understanding of the patients suffering from this disease, the burden of the disease and the healthcare consumption linked to this disease. Even if this consumption of care has been relatively unexplored until this point, it is not negligible. The potential of merging genomics and claims data for cardiovascular research could help to identify ways to optimize disease
|Condition or disease|
|Familial Chylomicronemia Syndrome Multifactorial Chylomicronemia Syndrome|
|Study Type :||Observational|
|Actual Enrollment :||140 participants|
|Official Title:||Medical Complications in Familial and Multifactorial Chylomicronaemia Syndromes From a 10 Year Follow-up Linking Datasets Between Patient Medical Records and Patient Claims: the ESTHYM Study|
|Actual Study Start Date :||March 1, 2018|
|Actual Primary Completion Date :||December 1, 2018|
|Actual Study Completion Date :||February 1, 2019|
Familial chylomicronaemia syndrome (FCS)
Multifactorial chylomicronemia syndrome
- Incidence of Acute Pancreatitis, Ischemic Cardiovascular Disease and any additional co-morbidity [ Time Frame: 2006-2016 (10 year follow-up) ]outcomes obtained by anonymous linkage with the Système National des Données de Santé (SNDS) national data base of any health resource consumption (> 40x106 subjects exhaustive compilation, linkage with Programme de médicalisation des systèmes d'information (PMSI) (diagnosis data base) and death registry)
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): NCT03912181
|Hospices Civils de Lyon|
|Principal Investigator:||Philippe Moulin, MD||Hospices Civils de Lyon|