Observational Registry of Advanced Cardiac Imaging in Systemic Lupus Erythematosus and Other Inflammatory diseaseS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 1,500
- Primary Endpoint
- MACE (major adverse cardiovascular events)
Study Overview
Brief Summary
Autoimmune diseases affect a total of 5 to 10% of the population. These diseases are associated with an increased risk of developing cardiovascular pathologies. Modern cardiac imaging tools could provide a better understanding of these complications, enabling earlier diagnosis and detection of patients most at risk. Yet, the diagnostic and prognostic value of multimodal cardiac imaging in these diseases is under-researched. The current registry aimed at investigating the diagnostic and prognostic value of cardiac imaging in autoimmune and systemic disorders.
Detailed Description
This is an observational prospective registry including patients with systemic disorders and autoimmune diseases who benefit from cardiac imaging. This is a single-center registry (Hôpital Pitié-Salpêtrière). Collected data at baseline include clinical, biological and imaging data. The study is not interventional. It includes data generated from routine care. The main objective is the characterization of the cardiovascular phenotype of patients with autoimmune, systemic and/or inflammatory diseases. Secondary objectives include the development and validation of prognostic biomarkers, the identification and quantification of specific risk factors for cardiovascular disease, and the evaluation of tolerance and efficacy of conventional and innovative therapies
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Suspected or diagnosed autoimmune, inflammatory and/or systemic disease.
- •Cross-sectional cardiac imaging including either nonenhanced cardiac computed tomography, enhanced coronary angiogram-computed tomography, or cardiac magnetic resonance imaging
Exclusion Criteria
- •Age < 18 years
- •Objection to study participation
- •Patient under legal protection
Outcomes
Primary Outcomes
MACE (major adverse cardiovascular events)
Time Frame: Through study completion, an average of 10 year
Composite outcome of myocardial infarction, stroke or cardiovascular death.
Secondary Outcomes
- Cardiovascular events (all)(Through study completion, an average of 10 year)
- ASCVD (atherosclerotic cardiovascular disease)(Through study completion, an average of 10 year)