LupusORACLESNCT07134166
Cardiac Imaging in Systemic Disorders: the ORACLES Registry
An observational study of Lupus, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus
- What is being tested?
- data collection
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Nov 2046
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Suspected or diagnosed autoimmune, inflammatory and/or systemic disease.
Who may be able to join
- 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
Who cannot join
- Age < 18 years
- Objection to study participation
- Patient under legal protection
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Observational Registry of Advanced Cardiac Imaging in Systemic Lupus Erythematosus and Other Inflammatory diseaseS
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
- Conditions
- Lupus
- Being tested
- data collection
- 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
- Medical subject headings
- Inflammation, Lupus Erythematosus, Systemic, Sarcoidosis, Vasculitis, Histiocytosis, Atherosclerosis, Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
data collection
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE (major adverse cardiovascular events)
Composite outcome of myocardial infarction, stroke or cardiovascular death.
Measured: Through study completion, an average of 10 year
Secondary outcomes (2)
ASCVD (atherosclerotic cardiovascular disease)
Composite outcome of acute coronary syndrome, stroke and peripheral artery disease.
Measured: Through study completion, an average of 10 year
Cardiovascular events (all)
MACE, ASCVD, device implantation, coronary artery disease, heart failure, rhythm and conduction disorders, valvular disorders, cardiovascular interventions, fatal and non fatal.
Measured: Through study completion, an average of 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study startNov 2026 (estimated)
- Primary completionNov 2046 (estimated)
- Study completionNov 2046 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LupusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134166
- Sponsor's protocol ID
- APHP250892
- Acronym
- ORACLES
- Status last verified
- Feb 2026
- First submitted
- 26 Jun 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Registry of Advanced Cardiac Imaging in Systemic Lupus Erythematosus and Other Inflammatory diseaseS
- ClinicalTrials.gov ID
- NCT07134166
- Acronym / sponsor ID
- ORACLES / APHP250892
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2046 (estimated)
- Study completion
- Nov 2046 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Suspected or diagnosed autoimmune, inflammatory and/or systemic disease.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Age < 18 years
- Objection to study participation
- Patient under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collectiondata collection | Other | – |
Primary outcome
MACE (major adverse cardiovascular events)
Time frame: Through study completion, an average of 10 year
Composite outcome of myocardial infarction, stroke or cardiovascular death.
2 secondary outcomes
ASCVD (atherosclerotic cardiovascular disease)
Time frame: Through study completion, an average of 10 year
Cardiovascular events (all)
Time frame: Through study completion, an average of 10 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lévi-Dan Azoulay, MD, MSc (01 42 16 00 00, levi-dan.azoulay@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (major adverse cardiovascular events) (time frame: Through study completion, an average of 10 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.