Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

INFLAME-BANK is a French multicenter prospective observational ancillary study of the international EACVI-INFLAME project. It aims to establish a biobank and perform immunophenotyping and proteomic analyses in patients with suspected inflammatory cardiovascular diseases and autoimmune rheumatic diseases (ICARDs).

The primary objective is to identify immune biomarkers associated with cardiovascular prognosis and develop disease-specific prognostic scores to predict 1-year major adverse cardiovascular events (MACE). Secondary objectives include evaluating the diagnostic and prognostic value of immunoproteomic biomarkers, assessing the role of photon-counting CT (PCCT) imaging, and investigating immune signatures associated with genetic variants in acute myocarditis.

The study plans to enroll 300 patients from French centers participating in EACVI-INFLAME. Blood samples will be collected during routine clinical care at inclusion, with optional follow-up sampling at 12 months and optional PCCT imaging and genetic analyses depending on each center's participation. Patients will be followed for 12 months to monitor cardiovascular outcomes.

The expected impact is to improve understanding of the immune mechanisms underlying ICARDs, facilitate earlier diagnosis and risk stratification, identify new therapeutic targets, and ultimately support more personalized management of patients with inflammatory cardiovascular diseases.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient enrolled in EACVI-INFLAME study

The patient consents

Disqualifiers

Patients with a history of heart transplant

Patient unable to provide informed consent

Patient under complete or limited guardianship

Patient affected by pre-existing immunodeficiency, including HIV (not including immunosuppressive treatment)

Trial population

Adults enrolled in the EACVI-INFLAME study with suspected or previously diagnosed inflammatory cardiovascular diseases (ICARDs) referred for cardiovascular magnetic resonance (CMR) and/or nuclear imaging, who provide informed consent.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Proportion of participants experiencing major adverse cardiovascular events (MACE) within 1 year of follow-up.

Occurrence of major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, hospitalization for heart failure, myocardial infarction, incidental atrial fibrillation, stroke, and recurrent ICARD, assessed at 1 year after inclusion.

Time frame
1years

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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