Medical Complications in Familial and Multifactorial Chylomicronaemia Syndromes

Completed

• Conditions: Familial Chylomicronemia Syndrome; Multifactorial Chylomicronemia Syndrome

• Registration Number: NCT03912181
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2018-12-01
• Study Completion: 2019-02-01
• Status Verified: 2019-04
• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-09
• Last Update Submitted: 2019-04-09
• Study First Posted: 2019-04-11
• Last Update Posted: 2019-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• genetically documented FCS
• genetically documented MCS

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Acute Pancreatitis, Ischemic Cardiovascular Disease and any additional co-morbidity	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)

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France