Cardiac Imaging in Systemic Disorders: the ORACLES Registry

NCT ID: NCT07134166

Last Updated: 2025-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-11-30

Study Completion Date

2046-11-30

Brief Summary

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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

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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

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Lupus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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data collection

data collection

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Lévi-Dan Azoulay, MD, MSc

Role: CONTACT

01 42 16 00 00

Alban Redheuil, MD, PhD

Role: CONTACT

01 42 16 00 00

Other Identifiers

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APHP250892

Identifier Type: -

Identifier Source: org_study_id

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