Immune Mediators and Metabolites to Stratify Systemic Lupus Erythematosus Patients at High Risk of Cardio Vascular Diseases
NCT ID: NCT04276701
Last Updated: 2024-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2021-03-10
2027-03-31
Brief Summary
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Thus there are multiple pathways that are shared between SLE and atherosclerosis and that may results in an increased risk of CV-associated morbidity in SLE patients. Exploring these interconnected pathways in SLE patients together with traditional and other well-established disease-related factors, might lead to a better stratification of CV risk in SLE.
The aim of this study is to investigate the accuracy, predictive value and utility of immunological disease-related biomarkers in stratifying CV risk in patients with SLE.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Systemic lupus erythematosus (SLE)
blood sample
35 ml whole blood for Peripheral blood mononuclear cell (PBMC), serum and plasma
Ultrasonography assessment
assessment of atherosclerotic plaques and measurement of carotid intima-media thickness (cIMT)
questionnaires
Food and exercise questionnaires validated by the American heart Association
Interventions
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blood sample
35 ml whole blood for Peripheral blood mononuclear cell (PBMC), serum and plasma
Ultrasonography assessment
assessment of atherosclerotic plaques and measurement of carotid intima-media thickness (cIMT)
questionnaires
Food and exercise questionnaires validated by the American heart Association
Eligibility Criteria
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Inclusion Criteria
* SLE diagnosis according to the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) Classification Criteria for Systemic Lupus Erythematosus
* Having signed an informed consent (at the latest on the day of inclusion and before any examination required by research).
Exclusion Criteria
* Person concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent
18 Years
ALL
No
Sponsors
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Foundation for Research in Rheumatology (FOREUM)
UNKNOWN
University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Pierre DUFFAU, Prof
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Patrick BLANCO, Prof
Role: STUDY_DIRECTOR
University Hospital, Bordeaux
Locations
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CHU de Bordeaux - service de médecine interne
Bordeaux, , France
CHU de Brest - service de rhumatologie
Brest, , France
CHRU de Lille - service de Médecine Interne
Lille, , France
AP-HP - Hôpital Cochin - service de Médecine Interne
Paris, , France
CHU de Strasbourg - service d'Immunologie Clinique
Strasbourg, , France
Universität Freiburg
Freiburg im Breisgau, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHUBX 2019/38
Identifier Type: -
Identifier Source: org_study_id
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