ClinicalTrials.gg
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.

Primary conditionLupus Erythematosus, SystemicRegistry: InflammationReclassifiedWhy we changed it
Registry
Inflammation — the first condition term the registry derived for this study.
ClinicalTrials.gg
Lupus Erythematosus, Systemic
Why
  1. Inflammation is a broad heading, used only when no more specific condition is named.
  2. The study's title name Lupus Erythematosus, Systemic.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

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

In context

Lupus Erythematosus, Systemic Reclassified

1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 151 across 280 observational studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Compared within Lupus Erythematosus, Systemic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammation. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Suspected or diagnosed , 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

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

06

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

07

Study locations

No study locations are listed for this record.

08

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, Informed consent form

Time frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor

Access criteria: Researchers who provide a methodologically sound proposal

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2046, 240 months later.

Of 88 non-industry observational studies under Lupus Erythematosus, Systemic, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 212. This study's planned 240 months is above that.

Counting every sponsor, half of 110 studies reached it within 64 months; a quarter within 34 and three quarters within 126.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 26, 2025
First posted
Aug 21, 2025
StartEst.
Nov 2026
Primary completionEst.
Nov 2046
CompletionEst.
Nov 2046
Last update
Feb 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07134166
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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Discussion

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