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Cardiac Imaging in Systemic Disorders: the ORACLES Registry

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07134166
Acronym
ORACLES
Enrollment
1500
Registered
2025-08-21
Start date
2026-11-01
Completion date
2046-11-01
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus

Keywords

Cardiac imaging, cardiac magnetic resonance imaging,, cardiac computed tomography, coronary angiogram computed tomography, coronary artery calcium, epicardial adipose tissue, inflammation, systemic lupus erythematosus, sarcoidosis, vasculitis, histiocytosis, atherosclerosis, myocarditis, corticosteroids, cytokines

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

Interventions

OTHERdata collection

data collection

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MACE (major adverse cardiovascular events)Through study completion, an average of 10 yearComposite outcome of myocardial infarction, stroke or cardiovascular death.

Secondary

MeasureTime frameDescription
ASCVD (atherosclerotic cardiovascular disease)Through study completion, an average of 10 yearComposite outcome of acute coronary syndrome, stroke and peripheral artery disease.
Cardiovascular events (all)Through study completion, an average of 10 yearMACE, ASCVD, device implantation, coronary artery disease, heart failure, rhythm and conduction disorders, valvular disorders, cardiovascular interventions, fatal and non fatal.

Contacts

CONTACTLévi-Dan Azoulay, MD, MSc
levi-dan.azoulay@aphp.fr01 42 16 00 00
CONTACTAlban Redheuil, MD, PhD
Alban.redheuil@aphp.fr01 42 16 00 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026