Cardiac Imaging in Systemic Disorders: the ORACLES Registry

NCT07134166 — Not yet recruiting, 1500 participants, Assistance Publique - Hôpitaux de Paris

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Observational Registry of Advanced Cardiac Imaging in Systemic Lupus Erythematosus and Other Inflammatory diseaseS

Registry	NCT07134166, acronym ORACLES
Status	Not yet recruiting
Study type	Observational
Enrollment	1500 (Estimated)
Sponsor	Assistance Publique - Hôpitaux de Paris (Other)
Conditions	Lupus
Interventions	data collection (Other)
Dates	start 2026-11-01 (estimated), primary completion 2046-11-01 (estimated), completion 2046-11-01 (estimated), first posted 2025-08-21, last updated 2026-02-13

-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.

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+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

+Arms and interventions

data collection (Other): data collection

+Outcome measures

Primary outcomes

MACE (major adverse cardiovascular events) [Through study completion, an average of 10 year]: Composite outcome of myocardial infarction, stroke or cardiovascular death.

Secondary outcomes

ASCVD (atherosclerotic cardiovascular disease) [Through study completion, an average of 10 year]: Composite outcome of acute coronary syndrome, stroke and peripheral artery disease.
Cardiovascular events (all) [Through study completion, an average of 10 year]: MACE, ASCVD, device implantation, coronary artery disease, heart failure, rhythm and conduction disorders, valvular disorders, cardiovascular interventions, fatal and non fatal.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Suspected or diagnosed autoimmune, inflammatory and/or systemic disease.
2. 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