NCT07134166

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
244mo left

Started Nov 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 21, 2025

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
20 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2046

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2046

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

20 years

First QC Date

June 26, 2025

Last Update Submit

February 11, 2026

Conditions

Lupus

Keywords

Cardiac imagingcardiac magnetic resonance imaging,cardiac computed tomographycoronary angiogram computed tomographycoronary artery calciumepicardial adipose tissueinflammationsystemic lupus erythematosussarcoidosisvasculitishistiocytosisatherosclerosismyocarditiscorticosteroidscytokines

Outcome Measures

Primary Outcomes (1)

  • MACE (major adverse cardiovascular events)

    Composite outcome of myocardial infarction, stroke or cardiovascular death.

    Through study completion, an average of 10 year

Secondary Outcomes (2)

  • ASCVD (atherosclerotic cardiovascular disease)

    Through study completion, an average of 10 year

  • Cardiovascular events (all)

    Through study completion, an average of 10 year

Interventions

data collectionOTHER

data collection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

InflammationLupus Erythematosus, SystemicSarcoidosisVasculitisHistiocytosisAtherosclerosisMyocarditis

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityVascular DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesCardiomyopathiesHeart Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Lévi-Dan Azoulay, MD, MSc

CONTACT

01 42 16 00 00levi-dan.azoulay@aphp.fr

Alban Redheuil, MD, PhD

CONTACT

01 42 16 00 00Alban.redheuil@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2025

First Posted

August 21, 2025

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

November 1, 2046

Study Completion (Estimated)

November 1, 2046

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF
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