Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07134166

Cardiac Imaging in Systemic Disorders: the ORACLES Registry

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Lupus Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Autoimmune Diseases Cardiomyopathies Cardiovascular Diseases Connective Tissue Diseases Heart Diseases Hemic and Lymphatic Diseases Histiocytosis Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Inflammation Lupus Erythematosus, Systemic Lymphatic Diseases Lymphoproliferative Disorders Myocarditis Pathologic Processes Pathological Conditions, Signs and Symptoms Sarcoidosis Skin and Connective Tissue Diseases Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

data collection

Primary outcomes

  1. 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

  1. ASCVD (atherosclerotic cardiovascular disease)

    Time frame: Through study completion, an average of 10 year

    Composite outcome of acute coronary syndrome, stroke and peripheral artery disease.

  2. Cardiovascular events (all)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alban Redheuil, MD, PhD

CONTACT

[email protected]

01 42 16 00 00

Lévi-Dan Azoulay, MD, MSc

CONTACT

[email protected]

01 42 16 00 00

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: ORACLES

Important dates

Study start
2026
Primary completion
2046
Study completion
2046
First posted
Aug 21, 2025
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.