INFLAMMATORY AND IMMUNE-MEDIATED DISEASES BIOBANKING FOR IMMUNOPHENOTYPING AND CARDIOVASCULAR RESEARCH

Detailed Description

INFLAME-BANK is a French multicenter prospective observational study conducted as an ancillary project of the international EACVI-INFLAME study. Its purpose is to establish a biobank of blood samples and perform advanced immunophenotyping and proteomic analyses in patients with suspected cardiovascular involvement related to inflammatory cardiovascular diseases and autoimmune rheumatic diseases (ICARDs).

The main objective of the study is to identify immune and proteomic biomarkers associated with cardiovascular prognosis and to develop disease-specific prognostic scores capable of predicting major adverse cardiovascular events (MACE) at 1 year. The primary endpoint is the proportion of patients experiencing MACE after one year of follow-up.

Secondary objectives include:

Characterizing baseline immunological and proteomic profiles in patients with suspected or confirmed ICARDs.

Evaluating the prognostic value of identified cellular and molecular biomarkers for individual cardiovascular outcomes, including cardiovascular death, heart failure hospitalization, ventricular arrhythmia, stroke, atrial fibrillation, recurrent ICARD, and remission.

Assessing the diagnostic utility of immuno-proteomic biomarkers for detecting cardiovascular involvement in ICARD patients.

Investigating the diagnostic and prognostic value of photon-counting computed tomography (PCCT) compared with other imaging modalities such as cardiovascular magnetic resonance (CMR) and transthoracic echocardiography (TTE).

Identifying inflammation signatures associated with desmosomal genetic variants in patients with acute myocarditis.

The study plans to enroll 300 patients from French centers participating in the EACVI-INFLAME protocol. Eligible participants are patients referred for CMR and/or nuclear imaging because of suspected cardiovascular involvement related to a suspected or previously diagnosed ICARD. Patients must be enrolled in the EACVI-INFLAME study and provide informed consent.

At inclusion, an additional 5 mL citrate blood sample will be collected during a routine blood draw, without any additional venipuncture specifically for the study. Depending on the participating center, optional procedures may include:

An additional blood sample at 12 months for plasma and/or peripheral blood mononuclear cell (PBMC) analysis.

Collection and centralized analysis of PCCT imaging data, including pseudonymized DICOM images.

Genetic testing by next-generation sequencing (NGS) in selected patients with acute myocarditis.

Participants will be followed for 12 months, with clinical data collected from electronic health records and entered into a secure electronic case report form (CleanWeb eCRF). The study will evaluate the occurrence of MACE, defined as a composite of cardiovascular death, hospitalization for heart failure, myocardial infarction, incidental atrial fibrillation, stroke, and recurrent ICARD.

Data analyses will include conventional statistical comparisons, survival analyses, and advanced high-dimensional analyses of immune cell populations and proteomic profiles. Mass cytometry (CyTOF) and mass spectrometry data will be processed using standardized normalization, clustering, dimensionality reduction, and differential expression analysis workflows.

The expected benefits of the study are substantial. INFLAME-BANK aims to improve understanding of the immune and molecular mechanisms underlying cardiovascular complications in inflammatory and autoimmune diseases, facilitate earlier diagnosis and risk stratification, support the development of personalized therapeutic strategies, and identify potential new targets for immunomodulatory or immunosuppressive treatments.

The additional risks associated with participation are considered minimal, as biological samples are collected during routine clinical care and no modification of standard patient treatment is required.

Inclusion criteria

• Patient enrolled in EACVI-INFLAME study 2. The patient consents

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Exclusion criteria

Non-inclusion criteria (patients fulfilling any of the following criteria are not eligible for inclusion in this study):

• Patients with a history of heart transplant 2. Patient unable to provide informed consent 3. Patient under complete or limited guardianship 4. Patient affected by pre-existing immunodeficiency, including HIV (not including immunosuppressive treatment)

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