Cardiac Imaging in Systemic Disorders: the ORACLES Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: data collection.
- Who it may be relevant to
- Registry conditions: Lupus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Observational Registry of Advanced Cardiac Imaging in Systemic Lupus Erythematosus and Other Inflammatory diseaseS
Overview
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
Interventions
- Other data collection
data collection
Primary outcome measures
- MACE (major adverse cardiovascular events) [Time frame: Through study completion, an average of 10 year]
Secondary outcome measures (2)
- ASCVD (atherosclerotic cardiovascular disease) [Time frame: Through study completion, an average of 10 year]
- Cardiovascular events (all) [Time frame: Through study completion, an average of 10 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07134166 · APHP250892