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Not yet recruitingNCT07134166ORACLESUpdated Feb 13, 2026

Cardiac Imaging in Systemic Disorders: the ORACLES Registry

An observational study in Lupus, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-13.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • Age \< 18 years
  • Objection to study participation
  • Patient under legal protection
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Interventions

  • Otherdata collection

    data collection

05

What researchers measure

Primary outcomes

  1. MACE (major adverse cardiovascular events)

    Composite outcome of myocardial infarction, stroke or cardiovascular death.

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

Secondary outcomes

  1. ASCVD (atherosclerotic cardiovascular disease)

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

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

  2. Cardiovascular events (all)

    MACE, ASCVD, device implantation, coronary artery disease, heart failure, rhythm and conduction disorders, valvular disorders, cardiovascular interventions, fatal and non fatal.

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

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Yes — The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

Supporting information: Study protocol, Icf

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07134166
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Aug 21, 2025
Start date
Nov 2026 (estimated)
Primary completion
Nov 2046 (estimated)
Completion
Nov 2046 (estimated)
Last update
Feb 13, 2026

Study contacts

Lévi-Dan Azoulay, MD, MSc
Contact
levi-dan.azoulay@aphp.fr
01 42 16 00 00
Alban Redheuil, MD, PhD
Contact
Alban.redheuil@aphp.fr
01 42 16 00 00

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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