Identifying high-risk cardiovascular patients with lupus
Immune Mediators and Metabolites to Stratify Systemic Lupus Erythematosus Patients at High Risk of Cardio Vascular Diseases
This study is trying to find out if certain immune markers in young women with lupus can help identify those at higher risk for heart problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 6 sites (Bordeaux and 5 other locations) |
| Trial ID | NCT04276701 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the relationship between immune mediators and metabolites in patients with systemic lupus erythematosus (SLE) to identify those at high risk for cardiovascular diseases. It focuses on young female SLE patients who are more susceptible to myocardial infarction compared to healthy individuals. The methodology includes blood sample analysis, ultrasonography assessments, and questionnaires to evaluate cardiovascular risk factors associated with SLE. The study seeks to uncover specific immunometabolites that may contribute to increased cardiovascular morbidity in these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients over 18 years old diagnosed with systemic lupus erythematosus according to established classification criteria.
Not a fit: Patients who are pregnant, breastfeeding, or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and targeted interventions for lupus patients at high risk of cardiovascular diseases.
How similar studies have performed: Other studies have indicated a link between immune dysregulation in SLE and cardiovascular risks, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient aged over 18 years old. * 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: * Pregnancy or breast-feeding for woman. * 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
Where this trial is running
Bordeaux and 5 other locations
- CHU de Bordeaux - service de médecine interne — Bordeaux, France (Recruiting)
- CHU de Brest - service de rhumatologie — Brest, France (Recruiting)
- CHRU de Lille - service de Médecine Interne — Lille, France (Recruiting)
- AP-HP - Hôpital Cochin - service de Médecine Interne — Paris, France (Not_yet_recruiting)
- CHU de Strasbourg - service d'Immunologie Clinique — Strasbourg, France (Recruiting)
- Universität Freiburg — Freiburg, Germany (Not_yet_recruiting)
Study contacts
- Principal investigator: Pierre DUFFAU, Prof — University Hospital, Bordeaux
- Study coordinator: Pierre DUFFAU, Prof
- Email: pierre.duffau@chu-bordeaux.fr
- Phone: (0)5 56 79 58 28
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.