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Cardiac Imaging in Systemic Disorders: the ORACLES Registry

A

Assistance Publique - Hôpitaux de Paris

Status

Begins enrollment in 8 months

Conditions

Lupus

Treatments

Other: data collection

Study type

Observational

Funder types

Other

Identifiers

NCT07134166
APHP250892

Details and patient eligibility

About

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.

Full 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

Enrollment

1,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

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Central trial contact

Lévi-Dan Azoulay, MD, MSc; Alban Redheuil, MD, PhD

Data sourced from clinicaltrials.gov

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